Why it was recalled
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Product description
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
Lot numbers, UPCs & expiration codes
Lot: 19454 Exp. 04/30/2019
Where it was sold
Nationwide.
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-1045-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 5, 2019
- FDA report date
- Mar 27, 2019
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AVKARE Inc.
Original FDA data
Every field from FDA enforcement report D-1045-2019, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 82314
- Address
- 615 N 1st St
- Code information
- Lot: 19454 Exp. 04/30/2019
- Postal code
- 38478-2403
- Report date
- Mar 27, 2019
- Product type
- Drugs
- Recall number
- D-1045-2019
- Classification
- Class II
- Recalling firm
- AVKARE Inc.
- Termination date
- Dec 7, 2020
- Reason for recall
- CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
- Distribution pattern
- Nationwide.
- Recall initiation date
- Mar 5, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2019