Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Product description
Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2
Lot numbers, UPCs & expiration codes
lot 0LE2178, Exp 1/31/2022; 0ME2516, Exp 4/30/2022
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-0341-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2021
- FDA report date
- Jan 12, 2022
- Quantity
- 48,816 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Perrigo Company PLC
Original FDA data
Every field from FDA enforcement report D-0341-2022, 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 0LE2178, Exp 1/31/2022; 0ME2516, Exp 4/30/2022
- Postal code
- 49010-9070
- Report date
- Jan 12, 2022
- Product type
- Drugs
- Recall number
- D-0341-2022
- Classification
- Class II
- Recalling firm
- Perrigo Company PLC
- Product quantity
- 48,816 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
- Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 27, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2022