Why it was recalled
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Product description
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
Lot numbers, UPCs & expiration codes
Arrow Malta (Teva) Bulk Product Lot # 1169752A, exp. date 01/2020, 1000 tablets/bottle 1169753A, exp. date 01/2020, 90 tablets/bottle Golden State Medical Finished Product Lot # GS017387, exp. date 01/2020 GS017651, exp. date 01/2020 GS017479, exp. date 01/2020
Where it was sold
Nationwide by 4 major distributors.
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-1455-2019
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 6, 2019
- FDA report date
- Jul 17, 2019
- Quantity
- 2,924,000 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1455-2019, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 83050
- Address
- 400 Interpace Pkwy
- Code information
- Arrow Malta (Teva) Bulk Product Lot # 1169752A, exp. date 01/2020, 1000 tablets/bottle 1169753A, exp. date 01/2020, 90 tablets/bottle Golden State Medical Finished Product Lot # GS017387, exp. date 01/2020 GS017651, exp. date 01/2020 GS017479, exp. date 01/2020
- Postal code
- 07054-1120
- Report date
- Jul 17, 2019
- Product type
- Drugs
- Recall number
- D-1455-2019
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 2,924,000 tablets
- Reason for recall
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
- Distribution pattern
- Nationwide by 4 major distributors.
- Recall initiation date
- Jun 6, 2019
- Initial firm notification
- Center classification date
- Jul 9, 2019