Recalls / Class I
Class ID-1255-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Tetracycline Hydrochloride
- Generic name
- Tetracycline Hydrochloride
- Active ingredient
- Tetracycline Hydrochloride
- Route
- Oral
- NDCs
- 23155-017, 23155-018
- FDA application
- NDA050278
- Affected lot / code info
- Lot # H190666, Exp JUL 2022
Why it was recalled
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Recalling firm
- Firm
- Avet Pharmaceuticals, Inc.
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 1700, N/A, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- 4,444 bottles
- Distribution pattern
- Distributed Nationwide in the US
Timeline
- Recall initiated
- 2020-03-23
- FDA classified
- 2020-04-27
- Posted by FDA
- 2020-04-15
- Terminated
- 2022-08-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1255-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.