Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Product description
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
Lot numbers, UPCs & expiration codes
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;
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0355-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2021
- FDA report date
- Jan 12, 2022
- Quantity
- 42,026 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Perrigo Company PLC
Original FDA data
Every field from FDA enforcement report D-0355-2022, exactly as published.
Show all FDA fields
- City
- Allegan
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 88384
- Address
- 515 Eastern Ave
- Code information
- 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;
- Postal code
- 49010-9070
- Report date
- Jan 12, 2022
- Product type
- Drugs
- Recall number
- D-0355-2022
- Classification
- Class II
- Recalling firm
- Perrigo Company PLC
- Product quantity
- 42,026 containers
- Termination date
- Nov 8, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 27, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2022