Clarithromycin 500mg Tablets (American Health) - CGMP investigation (2015)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
Brand
American Health Packaging
Lot Codes / Batch Numbers
Lot#: 132323, Exp 07/31/2015, Lot#: 132960, Exp 09/30/2015, Lot#: 133707A, Exp 10/31/2015, Lot#: 133707B, Exp 11/30/2015.
Products Sold
Lot#: 132323, Exp 07/31/2015; Lot#: 132960, Exp 09/30/2015; Lot#: 133707A, Exp 10/31/2015; Lot#: 133707B, Exp 11/30/2015.
American Health Packaging is recalling Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs due to CGMP Deviations: Firm did not adequately investigate customer complaints.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026