FDA Drug Recalls

Recalls / Class II

Class IID-1874-2019

Product

Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.

Affected lot / code info
Lot #: 067180024B1, 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
4536 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-1874-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.