Recalls / Class II
Class IID-1870-2019
Product
Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104.
- Affected lot / code info
- Lot #s: a) 067180010B, Exp 03/21; 067180024E1, Exp 07/21; b) 067180016A, Exp 05/21
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
- a) 10,992 cartons; b) 24,792 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-1870-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.