Why it was recalled
Failed Impurities/Degradation Specifications
Product description
fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.
Lot numbers, UPCs & expiration codes
Lot #'s: 067180009A, Exp 03/21; 067180013A, 067180014A, 067180015A, Exp 04/21; 067180018A, Exp 05/21; 067180020A, Exp 06/21; 067180021A1, 067180022A1, Exp 07/21; 06718028A1, 06718028B1, Exp 09/21; 06719001A3, Exp 01/22
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-1867-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 23, 2019
- FDA report date
- Sep 25, 2019
- Quantity
- 71,748 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurolife Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-1867-2019, exactly as published.
Show all FDA fields
- City
- Dayton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83581
- Address
- 2400 US Highway 130
- Code information
- Lot #'s: 067180009A, Exp 03/21; 067180013A, 067180014A, 067180015A, Exp 04/21; 067180018A, Exp 05/21; 067180020A, Exp 06/21; 067180021A1, 067180022A1, Exp 07/21; 06718028A1, 06718028B1, Exp 09/21; 06719001A3, Exp 01/22
- Postal code
- 08810-1519
- Report date
- Sep 25, 2019
- Product type
- Drugs
- Recall number
- D-1867-2019
- Classification
- Class II
- Recalling firm
- Aurolife Pharma, LLC
- Product quantity
- 71,748 bottles
- Termination date
- Aug 16, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 23, 2019
- Initial firm notification
- Letter
- Center classification date
- Sep 17, 2019