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 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated
Lot numbers, UPCs & expiration codes
GS017981 exp 02/2020, GS016958 exp 02/2020, GS017341 exp 02/2020
Where it was sold
IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. 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-1282-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 1, 2019
- FDA report date
- May 29, 2019
- Quantity
- 11,668 HDPE bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-1282-2019, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 82832
- Address
- 5187 Camino Ruiz
- Code information
- GS017981 exp 02/2020, GS016958 exp 02/2020, GS017341 exp 02/2020
- Postal code
- 93012-8601
- Report date
- May 29, 2019
- Product type
- Drugs
- Recall number
- D-1282-2019
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 11,668 HDPE bottles
- Termination date
- Feb 25, 2020
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated
- Distribution pattern
- IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.
- Recall initiation date
- May 1, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 19, 2019