Recalls / Class II
Class IID-1875-2019
Product
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
- Affected lot / code info
- Lot #s: 067180011A; 067180012A, Exp. 04/2021; 06718027B1 Exp. 09/2021
Why it was recalled
Failed Stability Specifications.
Recalling firm
- Firm
- AVKARE Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 5953 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-08-28
- FDA classified
- 2019-09-17
- Posted by FDA
- 2019-09-18
- Terminated
- 2021-10-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1875-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.