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 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
Lot numbers, UPCs & expiration codes
Arrow Malta (Teva) Bulk Product Lot # 1163892A, exp. date 01/2020 1163893A, exp. date 01/2020 1163894A, exp. date 01/2020 1163895A, exp. date 01/2020 Golden State Medical Finished Product Lot # GS017042, exp. date 01/2020 GS017043, exp. date 01/2020 GS017044, exp. date 01/2020 GS017541, 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-1456-2019
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 6, 2019
- FDA report date
- Jul 17, 2019
- Quantity
- 2,943,000 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1456-2019, 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 # 1163892A, exp. date 01/2020 1163893A, exp. date 01/2020 1163894A, exp. date 01/2020 1163895A, exp. date 01/2020 Golden State Medical Finished Product Lot # GS017042, exp. date 01/2020 GS017043, exp. date 01/2020 GS017044, exp. date 01/2020 GS017541, exp. date 01/2020
- Postal code
- 07054-1120
- Report date
- Jul 17, 2019
- Product type
- Drugs
- Recall number
- D-1456-2019
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 2,943,000 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 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
- Distribution pattern
- Nationwide by 4 major distributors.
- Recall initiation date
- Jun 6, 2019
- Initial firm notification
- Center classification date
- Jul 9, 2019