OR WAIT null SECS
April 04, 2018
April 03, 2018
The company is recalling Pasta De Lassar Andromaco zinc oxide diaper rash treatment after FDA analysis confirmed the product contained high levels of yeast, mold, and bacteria.
April 02, 2018
Implementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.
March 27, 2018
Telstar reports that its Boreas, a new 86° ultra-low-temperature freezer, increases average performance by 20%.
March 20, 2018
The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.
March 15, 2018
The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.
March 14, 2018
A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.
March 06, 2018
Twenty-first century drug development challenges sponsors and contract partners to collaborate more closely, using tools such as model-based simulation.
The company is recalling Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g manufactured by Gland Pharma Ltd and distributed by Sagent due to out-of-specification impurity results.
The company is recalling three lots of Hydromorphone HCl Injection USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials because of possibly empty or cracked vials.