Recalls / Class II
Class IID-0289-2022
Product
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
- Affected lot / code info
- Lot, expiry: Lot H00005, exp 01/2022; Lot H00006, exp 04/2022; Lot H00007, exp 07/2022
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- The Harvard Drug Group
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17187 N Laurel Park Dr Ste 300, N/A, Livonia, Michigan 48152-2600
Distribution
- Quantity
- 2,239 bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2021-08-03
- FDA classified
- 2021-12-21
- Posted by FDA
- 2021-12-29
- Terminated
- 2023-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0289-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.