Why it was recalled
Failed Stability Specifications.
Product description
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
Lot numbers, UPCs & expiration codes
Lot #s: 067180011A; 067180012A, Exp. 04/2021; 06718027B1 Exp. 09/2021
Where it was sold
Nationwide in the U.S.
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-1875-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 28, 2019
- FDA report date
- Sep 18, 2019
- Quantity
- 5953 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-1875-2019, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 83700
- Address
- 615 N 1st St
- Code information
- Lot #s: 067180011A; 067180012A, Exp. 04/2021; 06718027B1 Exp. 09/2021
- Postal code
- 38478-2403
- Report date
- Sep 18, 2019
- Product type
- Drugs
- Recall number
- D-1875-2019
- Classification
- Class II
- Recalling firm
- AVKARE Inc.
- Product quantity
- 5953 bottles
- Termination date
- Oct 27, 2021
- Reason for recall
- Failed Stability Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Aug 28, 2019
- Initial firm notification
- Letter
- Center classification date
- Sep 17, 2019