FDA Recall D-1255-2020
Avet Pharmaceuticals, Inc. · East Brunswick, NJ
Class I — life-threatening Terminated 883 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Recall record
- Recall number
D-1255-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed Nationwide in the US
- Recall initiated
- 2020-03-23
- Classified by FDA Center
- 2020-04-27
- FDA published
- 2020-04-15
- Terminated
- 2022-08-23
- Recalling firm
- Avet Pharmaceuticals, Inc.
- Firm location
- East Brunswick, NJ
Drug identification
- Brand name(s)
- TETRACYCLINE HYDROCHLORIDE
- Generic name(s)
- TETRACYCLINE HYDROCHLORIDE
- Manufacturer(s)
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- NDC(s)
23155-017, 23155-018- Route(s)
- ORAL