Why it was recalled
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Product description
EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.
Lot numbers, UPCs & expiration codes
Lot # a)0HE2530 Exp 12/31/2021, 0KE2980 EXP 02/28/2022 b)0FR0461 Exp 2/28/2022
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-0328-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2021
- FDA report date
- Jan 12, 2022
- Quantity
- 55,032 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Perrigo Company PLC
Original FDA data
Every field from FDA enforcement report D-0328-2022, 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 # a)0HE2530 Exp 12/31/2021, 0KE2980 EXP 02/28/2022 b)0FR0461 Exp 2/28/2022
- Postal code
- 49010-9070
- Report date
- Jan 12, 2022
- Product type
- Drugs
- Recall number
- D-0328-2022
- Classification
- Class II
- Recalling firm
- Perrigo Company PLC
- Product quantity
- 55,032 units
- 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
- EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 27, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2022