Recalls / Class II
Class IID-1864-2019
Product
Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21
- Affected lot / code info
- Lot #: 067180008A, Exp 03/21
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
- 8,240 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-1864-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.