Recalls / Class II
Class IID-0346-2022
Product
Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-425-78 UPC 3 45802 425 78 2
- Affected lot / code info
- Lot# 0CR0510, Exp 09/30/21, 0GR0445, Exp 01/31/22, 0LR0361, Exp 04/30/22, 1AR0558 , Exp 07/31/22
Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Recalling firm
- Firm
- Perrigo Company PLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, N/A, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 41,472 containers
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-07-27
- FDA classified
- 2022-01-05
- Posted by FDA
- 2022-01-12
- Terminated
- 2022-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0346-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.