Drug product
Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01
D-1254-2020
Product summary
- Event
- Event 85307
- Status
- Terminated
- Classification
- Class I
- Quantity
- 17,524 bottles
- Official record key
drug-enforcement:D-1254-2020
Official wording
Reason: Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Code information: Lot #s: G190609, G190610, G190611, Exp Jun 2022: L191027, L191028, Exp Nov 2022: K190953, K190952, Exp Oct 2022
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Potency or specification failure
Out of specification