Drug product
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
D-0014-2026
Product summary
- Event
- Event 97716
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,680 500-count bottles
- Official record key
drug-enforcement:D-0014-2026
Official wording
Reason: Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Code information: Lot #: P24ZLK1, Exp 5/31/2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications