Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Product description
H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9
Lot numbers, UPCs & expiration codes
Lot 0JE2491, 0LE2178, Exp 01/31/2022; 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-0339-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2021
- FDA report date
- Jan 12, 2022
- Quantity
- 26,304 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Perrigo Company PLC
Original FDA data
Every field from FDA enforcement report D-0339-2022, 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 0JE2491, 0LE2178, Exp 01/31/2022; 0ME2516, Exp 4/30/2022
- Postal code
- 49010-9070
- Report date
- Jan 12, 2022
- Product type
- Drugs
- Recall number
- D-0339-2022
- Classification
- Class II
- Recalling firm
- Perrigo Company PLC
- Product quantity
- 26,304 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
- H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 27, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2022