Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Product description
Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
Lot numbers, UPCs & expiration codes
Major Label Unit Does 10 x 10 Cartons, Major Item # 301835. Lot Number: R-00474. Expiration date: 07/2019.
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-1466-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 10, 2019
- FDA report date
- Jul 17, 2019
- Quantity
- 3,102 Cartons (310,200 tablets)
- Recalling firm
- MAJOR PHARMACEUTICALS
Original FDA data
Every field from FDA enforcement report D-1466-2019, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 83208
- Address
- 17177 N Laurel Park Dr
- Code information
- Major Label Unit Does 10 x 10 Cartons, Major Item # 301835. Lot Number: R-00474. Expiration date: 07/2019.
- Postal code
- 48152-2693
- Report date
- Jul 17, 2019
- Product type
- Drugs
- Recall number
- D-1466-2019
- Classification
- Class II
- Recalling firm
- MAJOR PHARMACEUTICALS
- Product quantity
- 3,102 Cartons (310,200 tablets)
- Termination date
- Feb 19, 2023
- Reason for recall
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
- Product description
- Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jan 10, 2019
- Center classification date
- Jul 9, 2019