Drug product
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
D-0471-2025
Product summary
- Event
- Event 96907
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,608 bottles
- Official record key
drug-enforcement:D-0471-2025
Official wording
Reason: cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Code information: Lot#: AEF124004A, Exp date 08/31/2026
Distribution pattern: USA Nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP deviations