Recalls / Class II
Class IID-1867-2019
Product
fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.
- Affected lot / code info
- Lot #'s: 067180009A, Exp 03/21; 067180013A, 067180014A, 067180015A, Exp 04/21; 067180018A, Exp 05/21; 067180020A, Exp 06/21; 067180021A1, 067180022A1, Exp 07/21; 06718028A1, 06718028B1, Exp 09/21; 06719001A3, Exp 01/22
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Aurolife Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 US Highway 130, N/A, Dayton, New Jersey 08810-1519
Distribution
- Quantity
- 71,748 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-08-23
- FDA classified
- 2019-09-17
- Posted by FDA
- 2019-09-25
- Terminated
- 2022-08-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1867-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.