Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Product description
Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 count bottle, Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 NDC 11822-0425-0 UPC 0 11822 85410 8
Lot numbers, UPCs & expiration codes
Lot # 0JE2487, EXP 01/31/2022; 0ME2515, Exp 04/30/2022
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-0347-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2021
- FDA report date
- Jan 12, 2022
- Quantity
- 79,776 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Perrigo Company PLC
Original FDA data
Every field from FDA enforcement report D-0347-2022, 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 # 0JE2487, EXP 01/31/2022; 0ME2515, Exp 04/30/2022
- Postal code
- 49010-9070
- Report date
- Jan 12, 2022
- Product type
- Drugs
- Recall number
- D-0347-2022
- Classification
- Class II
- Recalling firm
- Perrigo Company PLC
- Product quantity
- 79,776 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
- Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 count bottle, Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 NDC 11822-0425-0 UPC 0 11822 85410 8
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 27, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2022