Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Product description
GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
Lot numbers, UPCs & expiration codes
60429-640-90 Irbesartan 75mg Tablets, 90 Count Bottle B160003 Sep-19 B160004 Sep-19
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-0270-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 29, 2018
- FDA report date
- Nov 28, 2018
- Quantity
- 3,835 HDPE bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sciegen Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0270-2019, exactly as published.
Show all FDA fields
- City
- Hauppauge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 81458
- Address
- 89 Arkay Dr
- Code information
- 60429-640-90 Irbesartan 75mg Tablets, 90 Count Bottle B160003 Sep-19 B160004 Sep-19
- Postal code
- 11788-3727
- Report date
- Nov 28, 2018
- Product type
- Drugs
- Recall number
- D-0270-2019
- Classification
- Class II
- Recalling firm
- Sciegen Pharmaceuticals Inc
- Product quantity
- 3,835 HDPE bottles
- Termination date
- Sep 25, 2023
- Reason for recall
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 29, 2018
- Initial firm notification
- Press Release
- Center classification date
- Nov 20, 2018