Glenmark Pharmaceuticals Inc., USA — Class II: Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenm
Glenmark Pharmaceuticals Inc., USA has initiated a Class II recall for Azelaic Acid Gel, 15% (50 gram tubes) due to CGMP deviations involving product quality complaints regarding abnormal texture or consistency, described as grainy, gritty, or sandy.
This recall affects Glenmark Pharmaceuticals Inc., USA, and specifically impacts personnel involved in the manufacturing, quality control, and distribution of topical dermatological drug products.
The classification as a Class II recall suggests that while the health hazard is not likely to be immediate or life-threatening, the underlying CGMP deviations indicate a failure in manufacturing consistency or formulation stability. The source indicates that the issue was identified through product quality complaints, highlighting the importance of robust post-market surveillance in identifying manufacturing defects that may not be apparent during initial release testing.
QA and Manufacturing teams should evaluate existing physical stability testing protocols and retain sample inspection procedures to ensure they can detect changes in texture or consistency over the product shelf life. Regulatory departments should ensure complaint handling systems are sensitized to 'abnormal texture' reports as potential indicators of CGMP deviations.
Class II. Reason: CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.. Product: Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.. Firm: Glenmark Pharmaceuticals Inc., USA (Elmwood Park NJ United States). Status: Ongoing.
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