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 tablets, 90 count bottle, NDC 60429-317-90
Lot numbers, UPCs & expiration codes
Lot #: GS017651, Expiration 01/2020
Where it was sold
US Nationwide One (1) US government account. No foreign accounts.
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-1463-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 14, 2019
- FDA report date
- Jul 17, 2019
- Quantity
- 14,955 bottles (1,345,950 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-1463-2019, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 83161
- Address
- 5187 Camino Ruiz
- Code information
- Lot #: GS017651, Expiration 01/2020
- Postal code
- 93012-8601
- Report date
- Jul 17, 2019
- Product type
- Drugs
- Recall number
- D-1463-2019
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 14,955 bottles (1,345,950 tablets)
- Termination date
- Feb 19, 2020
- 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 tablets, 90 count bottle, NDC 60429-317-90
- Distribution pattern
- US Nationwide One (1) US government account. No foreign accounts.
- Recall initiation date
- Jun 14, 2019
- Center classification date
- Jul 9, 2019