Recalls / Class II
Class IID-0354-2022
Product
amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Amazon.com services LLC 410 Terry Avenue N., Seattle WA 98109, NDC 72288-425-78 UPC 3 70030 14536 2
- Affected lot / code info
- Lot # 1AR0558, Exp 7/31/2022
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
- 38,352 bottles
- 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-0354-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.