Recalls / Class II
Class IID-0355-2022
Product
KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech Republic, Packaged by Perrigo 515 Eastern Ave., Allegan, MI 49010, For Costco Wholesale Corporation. P.O. Box 34535 Seattle, WA 98124-1535, NDC 63981-571-48, UPC 0 96619 98776 4
- Affected lot / code info
- Lot # 0HV1246, exp 1/1/2022; 0GV1974, 0GV1459, exp 2/1/2022, 0HV1438, exp 3/1/2022, 0KV2116, 0KV2117, exp 5/1/2022; 0KV2119, 0LV2196, 0MV2203, 0MV2204, 0MV2205, exp 6/1/2022;
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
- 42,026 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-0355-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.