Drug product
Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01
D-1255-2020
Product summary
- Event
- Event 85307
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4,444 bottles
- Official record key
drug-enforcement:D-1255-2020
Official wording
Reason: Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Code information: Lot # H190666, Exp JUL 2022
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Potency or specification failure
Out of specification