FDA Drug Recalls

Recalls / Class II

Class IID-1869-2019

Product

Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62.

Affected lot / code info
Lot #s: 067180010A, Exp 03/21; 067180023C1, 067180024D1, Exp 07/21

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
129,600 cartons
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-1869-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.