Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785.
Lot numbers, UPCs & expiration codes
Lot #s: a) 067180025D1, Exp 07/21; b) 067180025B1, Exp 07/21; c) 067180025A1, Exp 07/21; d) 067180025C1, Exp 07/21
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-1865-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 23, 2019
- FDA report date
- Sep 25, 2019
- Quantity
- a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurolife Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-1865-2019, 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: a) 067180025D1, Exp 07/21; b) 067180025B1, Exp 07/21; c) 067180025A1, Exp 07/21; d) 067180025C1, Exp 07/21
- Postal code
- 08810-1519
- Report date
- Sep 25, 2019
- Product type
- Drugs
- Recall number
- D-1865-2019
- Classification
- Class II
- Recalling firm
- Aurolife Pharma, LLC
- Product quantity
- a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons
- Termination date
- Aug 16, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 23, 2019
- Initial firm notification
- Letter
- Center classification date
- Sep 17, 2019