Susan Haigney

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FDA announced on Aug. 27, 2025 that Unichem Pharmaceuticals (USA) has voluntarily recalled one lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg. The recall was initiated because the Cyclobenzaprin label was placed on a bottle that contained Meloxicam 7.5 mg tablets.

While the company has not received any reports of adverse events as of the date of the recall notice, if Meloxicam is taken unknowingly, serious events could result, such as cardiovascular, gastrointestinal, renal, anaphylaxis, and skin reactions. This is especially the case for patients taking concomitant non-steroidal anti-inflammatory drugs (NSAIDs) or blood thinners.

Cyclobenzaprine Hydrochloride Tablets USP 10 mg is used as a muscle relaxer and as an add-on treatment to physical therapy to relieve muscle spasms that result from acute musculoskeletal conditions.Meloxicam Tablets USP, 7.5 mg, however, is a NSAID used for osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis.

Customers can tell the difference between the two drugs by their description. Cyclobenzaprine Hydrochloride Tablets USP 10 mg are round, biconvex tablets that are blue in color and film coated, with a “U” debossed on one side and “12” debossed on the other side. Meloxicam Tablets USP, 7.5 mg is a light yellow, round, flat beveled-edged tablet that has “U & L” debossed on one side and “7.5” debossed on the center of the other side.

The recalled lot is lot number GMML24026A, has an expiry date of Sept 2027, and NDC 29300-415-19 printed on the label of the 90-count bottles. It was distributed nationwide to distributers and downstream to retailers and consumers.

The recall is being conducted by a third-party provider, Inmar, which is notifying distributors, retailers, and consumers and arranging for return of the recalled product. “Our downstream trading partners that have Cyclobenzaprine Hydrochloride Tablets USP, 10mg with Lot# GMML24026A, Exp Sept 2027, which is being recalled, should not further distribute this medication, and notify their customers accordingly. Retail pharmacies should not dispense from this lot number, GMML24026A, and call the number provided for guidance on how to return this drug product. Any pharmacy who has dispensed this lot of Cyclobenzaprine, should notify the consumer. Consumers should return the medication to the pharmacy they received their prescription from,” the company stated in a press release (1).

Adverse events can be reported to FDA via the agency’s MedWatch Adverse Event Reporting program. 

Regulatory agencies inspect manufacturing facilities to, in part, to prevent these types of recalls, which can be caused by human error or a lack of good manufacturing practice procedures. The agency will often issue form 483 and/or a warning letter to drug manufacturers to advise them of changes needed to their procedures or facilities so that recalls can be avoided.

In an article published in PharmTech Group’s 

, experts from Sia/LBG review some of the most common findings from FDA 483s and suggest strategies for preventing regulatory non-compliance.

“Issuance of an FDA Form 483 or a warning letter could be regarded in some way as a potential barometer of regulatory performance, but if a company acts responsibly and thoroughly, they can resolve the concerns quickly and professionally to minimize potential impacts and maintain and improve compliance over time,” the authors state (2).

FDA. Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling. Press Release. Aug. 27, 2025. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unichem-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-cyclobenzaprine-hydrochloride

Falvey, P.; Sloboda, G.; DeDonder, S.;Schoukroun-Barnes, L. New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s. 

https://www.pharmtech.com/view/new-year-same-challenges-pharma-s-ongoing-struggle-with-fda-483s

Articles

Unichem Pharmaceuticals has issued a voluntary recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg after the incorrect label was placed on the wrong product.

Mislabeling Leads to Cyclobenzaprine Hydrochloride Recall

Ask the Expert: Studies for Extractables and Leachables

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, talks to Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs, and Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions, about extractables and leachables (E&L). Specifically, Christiaens and Jenke highlight the differences between the E and the L in E&L and how these two compounds play off each other. Jenke goes into detail about the requirements for leachable studies, while Christiaens provides clarification on what is necessary for extractables.

“The design requirements for leachable studies are pretty clearly outlined in the global regulations,” says Jenke. “That's things like, use three batches of drug product. You use multiple time points over nominal shelf life and accelerated shelf life in order to establish trends. You use drug product units that represent commercial product. In other words, the formulation is the commercial formulation, the packaging is the commercial packaging, and the product has been manufactured using the commercial manufacturing process. There's the expectation that an eligible study has two components, targeted components, where you know it's exactly what it sounds. You know what the compounds are that you need to measure, and you validate [them]. You validate methods to do those measurements. The second component is a screening or non-target component, where you don't necessarily know what the compounds are that you're looking for, and you use qualified methods to look for these compounds above a reporting threshold. The analytical methods themselves, at least in terms of high-level, are relatively well established.”

“During a stability study, you have your different time points, and gradually you see those compounds coming out of the container closure system,” Christiaens says. “If you would not do that, then you would do some kind of impurities profiling of your drug product. That means that you would see everything that is present in the drug product without any differentiation between, is it eligible or not? And that is very important in terms of conclusions. You only want to report in this phase what is coming out of the container closure system and nothing else, because the other things will normally have been addressed in other studies. So, you don't need to repeat that over again.”

Click the video above to watch Piet and Dennis answer the following questions:

“What are the critical points in an E&L study that really need to be addressed before even considering a submission to the health authorities?”

“My company recently performed E&L studies on a product using different approaches and got different results each time. How can we be sure which results are ‘correct’?”

Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs

Piet Christiaens, PhD, is scientific director, E&L expert at Nelson Labs. Dr. Christiaens develops analytical methods and protocols for both extractables and leachables studies for the pharmaceutical and medical industries.

Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions.

Dennis Jenke, PhD, is principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions. Dr. Jenke supports the customers of Nelson Labs Europe in the discussion of general principles, concepts, tactics, and/or strategy related to chemical characterization and qualification of materials, components, and systems used in these industries.

Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates

Susan J. Schniepp is distinguished fellow at Regulatory Compliance Associates and a member of 

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

Videos

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, talks to Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs, and Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions, about extractables and leachables and the testing required for each.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Nelson Labs announced on Aug. 26, 2025 that it is expanding its state-of-the-art laboratory space at its Wiesbaden, Germany facility (1). The expansion comes as a response to what the company says is a growing demand for packaging and microbiological testing. The company provides microbiological testing, analytical chemistry testing, and advisory services to the pharmaceutical industry.

The Wiesbaden facility offers end-to-end sterility assurance services, including Sterigenics sterilization. Sterigenics, A Sotera Health company, is a provider of outsourced terminal sterilization and irradiation services for a variety of industries.

What new services will the expansion provide?

The investment will enhance the site’s packaging validation and microbiological testing capabilities for medical device and pharmaceutical customers. The facility will be fully operational throughout the expansion. Included in the expansion are four new laboratories for packaging testing services that will enhance current microbiological testing capacity. These labs will be able to perform endotoxin, bioburden, ethylene oxide residual testing, and biological indicator sterility testing. Packaging integrity services will also be introduced. A full suite of packaging testing services will include strength testing, integrity testing, container closure integrity testing, microbial barrier testing, aging studies, and distribution testing. Improvements will also be made to bioburden testing, featuring separate sample, personnel entry points and high efficiency particulate air (HEPA)-filtered air systems to ensure contamination control.

In June 2025, Nelson Labs announced an expansion at its Salt Lake City headquarters to double the lab’s existing ISO-certified cleanroom capacity to support sterility assurance testing and align with the European Union’s good manufacturing practice requirements (2). Enhancements to the Salt Lake facility include a new isolator suite, zoned HEPA filtration, and upgraded laminar airflow systems.

Nelson Labs has more than 3000 customers and 12 facilities in the United States, Mexico, Asia, and Europe with more than 900 laboratory tests. Additionally, Regulatory Compliance Associates, a Nelson Labs company, provides regulatory consulting services.

®’s Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, moderates a discussion between Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs, and Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions, about extractables and leachables and the testing required for each (3).

Specifically, Christiaens and Jenke highlight the differences between the E and the L in E&L and how these two compounds play off each other. Jenke goes into detail about the requirements for leachable studies, while Christiaens provides clarification on what is necessary for extractables.

The episode is available on Aug. 28, 2025. Visit PharmTech.com to watch the discussion. 

https://www.pharmtech.com/view/ask-the-expert-studies-for-extractables-and-leachables

Nelson Labs. Nelson Labs Expands Laboratory Capacity and Services in Wiesbaden, Germany to Meet Growing Demand for Packaging and Microbiological Testing. Press Release. Aug. 27, 2025.

Nelson Labs. Nelson Labs to Double Cleanroom Capacity to Support Growing Demand for Sterility Assurance Services. Press Release. June 11, 2025.

Schniepp, S. and Haigney, S. Ask the Expert: Studies for Extractables and Leachables. 

Nelson Labs is expanding its Wiesbaden, Germany facility to meet increasing demand for packaging and microbiological testing. The expansion includes four new laboratories for packaging testing services, enhancing microbiological testing capacity with endotoxin, bioburden, ethylene oxide residual, and biological indicator sterility testing. Packaging integrity services will also be introduced. Concurrently, Nelson Labs is doubling its cleanroom capacity at its Salt Lake City headquarters to support sterility assurance testing. Additionally, a discussion on extractables and leachables testing is featured in Pharmaceutical Technology®’s Ask the Expert video series.

The laboratory services provider is responding to growing demand for packaging and microbiological testing by expanding its laboratory space at its Wiesbaden, Germany, facility.  

Nelson Labs Expands Laboratory Capacity and Services at German Facility

The Impact of FDA’s Guidance on Clinical Trials for Radiopharmaceuticals

On Aug. 18, 2025, FDA published a draft guidance, titled 

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development

, that was created to assist drug sponsors with identifying an optimized dosage for radiopharmaceutical therapies for cancer indications during clinical development (1). The guidance addresses clinical development before submitting a marketing application for a new indication and usage.

® spoke with Michael Ritchie, chief commercial officer of Champions Oncology, to find out how the new guidance might impact the development and approval of radiopharmaceuticals and what some of the challenges are for conducting clinical trials for these treatments.

“Radio pharmaceuticals have been around for about 100 years, and classical radiopharma relied on something called EBRT, or external beam radiotherapy, and that is essentially delivering a radio beam to the patient from an external source,” Ritchie says. “But we're now looking at a new wave of therapies which are injected systemically, and quite frankly, we just don't know enough about them. FDA has released new guidance that has said, hey, we want you to come to the table with a better understanding of pharmacodynamics potential liabilities from a toxicity perspective, therapeutic window. But we also want you to design your clinical trials in such a way that we can get an idea on dosimetry.”

Click the video above to watch the full interview.

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development. Draft Guidance for Industry

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-therapeutic-radiopharmaceuticals-dosage-optimization-during-clinical-development

To find out how FDA’s new draft guidance, Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development, may impact the development of radiopharmaceuticals as cancer treatments, Pharmaceutical Technology® spoke with Michael Ritchie, chief commercial officer of Champions Oncology. 

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

On Aug. 21, 2025, Johnson & Johnson (J&J) announced it will be adding a more than 160,000-square-foot dedicated manufacturing facility at the FUJIFILM site in Holly Springs, NC. This will be part of a $2 billion expansion during the next 10 years to expand J&J’s manufacturing capacity in the United States. The facility will focus on the manufacture of advanced medicines. The company stated it also has plans for adding more advanced manufacturing facilities in the US and expanding current US facilities.

“Johnson & Johnson has more manufacturing facilities in the US than in any other country, and we continue to strengthen our presence here,” said Joaquin Duato, chairman and chief executive officer, Johnson & Johnson, in a press release (1). “With the recent signing of the One Big Beautiful Bill Act, we continue to expand our investment in the US to lead the next era of healthcare innovation.”

In March 2025, J&J announced the investment of $55 billion in US manufacturing, R&D, and technology over the next four years, including the following:

Construction of a facility in Wilson, NC, that will employ more than 500 people when fully operational and create approximately 5000 construction jobs during the site development

R&D infrastructure to develop lifesaving and life-changing treatments in areas such as oncology, neuroscience, immunology, cardiovascular disease, and robotic surgery.

“Today’s announcements accelerate our nearly 140-year legacy as an American innovation engine tackling the world’s toughest healthcare challenges,” Duato said in a press release at the time (2). “Our increased US investment begins with the ground-breaking of a high-tech facility in North Carolina that will not only add US-based jobs but manufacture cutting-edge medicines to treat patients in America and around the world.”

In early August 2025, J&J was one of the companies on the receiving end of letters sent by the Trump administration insisting prescription drug prices be lowered in the US. In what has been called a most-favored-nation price strategy, the White House has been in talks with pharmaceutical companies about ways drug pricing can be reduced (3).

The ongoing tariff situation has also been making impacts in the pharmaceutical industry.

® reached out to readers to find out how the tariffs may have impacted those working in the industry. A survey found that tariff-driven costs are rising, and the supply is strained, with nearly half of respondents reporting that the tariffs will ‘significantly’ impact their operations or the supply chain (4).

Other companies making an investment in the US

J&J isn’t the only pharmaceutical company making an investment in US facilities. On Aug. 13, 2025, AbbVie announced it was expanding US API production with a $195 million investment in a manufacturing plant in North Chicago, Ill., allowing the company to deepen its chemical synthesis capabilities in the US (5).

Bora Pharmaceuticals also announced an investment in August. The company will be expanding manufacturing and packaging capability at its Maple Grove, Minn. facility (6). In July, AstraZeneca announced a $50 billion investment in manufacturing and R&D US facilities by 2030 (7). And in June 2025, Hikma Pharmaceuticals announced it was putting $1 billion into expanding generic-drug R&D and manufacturing in Ohio and New Jersey (8).

J&J. Johnson & Johnson Continues U.S. Investment with $2 Billion Commitment to Enable Manufacturing at State-Of-The-Art North Carolina Facility. Press Release. Aug. 21, 2025. 

https://www.jnj.com/media-center/press-releases/johnson-johnson-continues-u-s-investment-with-2-billion-commitment-to-enable-manufacturing-at-state-of-the-art-north-carolina-facility

J&J. Johnson & Johnson Increases US Investment to More than $55 Billion Over the Next Four Years. Press Release. March 21, 2025.

Lavery, P. Trump Sends Letters to 17 Leading Pharma Companies Outlining Most-Favored-Nation Drug Pricing Protocol. PharmTech.com. Aug. 1, 2025. 

https://www.pharmtech.com/view/trump-sends-letters-17-leading-pharma-companies-outlining-most-favored-nation-drug-pricing-protocol

Cole, C. Bio/Pharma’s Tariff Response: Key Insights from Industry Survey Results. PharmTech.com. Aug. 20, 2025. 

https://www.pharmtech.com/view/biopharma-pharmaceutical-industry-tariff-response-key-insights-from-industry-survey-results

AbbVie Announces $195 Million Investment to Expand Active Pharmaceutical Ingredient Manufacturing in the US.

Bora Pharmaceuticals Announces Multi-Year Expansion for Midwest Manufacturing Site, as Upsher-Smith Entity Split is Finalized.

AstraZeneca Plans to Invest $50 Billion in America for Medicines Manufacturing and R&D.

Hikma Pharmaceuticals USA Announces $1 Billion of New US Investment to Further Expand its Domestic Manufacturing and Development of Essential Generic Medicines.

Johnson & Johnson is investing $2 billion over the next decade to expand its US manufacturing capacity, starting with a new facility in North Carolina. This is part of a broader $55 billion investment in US manufacturing, R&D, and technology announced in March 2025. The expansion aims to enhance the production of advanced medicines and create significant employment opportunities. Concurrently, the Trump administration is pressuring pharmaceutical companies to lower drug prices. Other companies, including AbbVie and AstraZeneca, are also making substantial investments in US facilities.

The company will be adding a 160,000-square-foot dedicated manufacturing facility at the FUJIFILM site in Holly Springs, NC.

Johnson & Johnson Invests $2 Billion into North Carolina Facility

The Impact of Reclassifying 7-OH Products

On Aug. 14, 2025, Florida Attorney General James Uthmeier issued an emergency rule filing to classify certain 7-hydroxymitragynine (7-OH) products as Schedule 1 controlled substances in Florida, making it illegal to sell, possess, or distribute certain 7-OH drugs in the state (1). This action follows FDA’s July 2025 recommendations to control concentrated 7-OH products under the Controlled Substances Act. Those recommendations now head to the Drug Enforcement Agency for review (2).

To find out how these government actions may impact the pharmaceutical industry, 

® spoke with C. Michael White, distinguished professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and chair of the Kratom Consumer Advisory Council. White sees the actions as helping pharmaceutical manufacturers combat those companies wishing to circumvent regulations.

“Pharmaceutical companies have to spend a billion or more dollars in order to be able to bring their drugs to market and have to be able to prove the benefits and the risks of those products. Here, you don't have to do any of that. All you have to do is take a product, put it in a well-marketed form, and then just put it out on the shelves and see what happens. And that's not a good way to be able to have a healthcare system,” White says. “So, I think [FDA’s and Florida’s decision] is going to be good, because it helps to underscore that there should be one way that these chemicals are coming out onto the market and that it's the same level playing field for everyone.”

Click the video above to watch the interview.

Makary, M.A. Statement from FDA Commissioner Marty Makary, MD, MPH, on Florida Restriction of 7-OH Opioid Products. 

https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-florida-restriction-7-oh-opioid-products

FDA. FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers. Press Release. July 29, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers

C. Michael White is Distinguished Professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy. He is also the Chair of the Kratom Consumer Advisory Council. He has been a clinical pharmacology and evidence synthesist researcher for more than 27 years and focuses on reducing drug, dietary supplement, device, and procedure-induced diseases.

Pharmaceutical Technology® spoke with C. Michael White, distinguished professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and chair of the Kratom Consumer Advisory Council, about recent government actions regarding kratom and concentrated 7-hydroxymitragynine (7-OH) products.