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, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
Lot numbers, UPCs & expiration codes
60429-642-30 Irbesartan 300mg Tablets, 30 Count Bottle GS019036 Sep-19 GS019073 Sep-19 GS021472 Nov-19 GS021530 Nov-19 GS022234 Feb-20 60429-642-90 Irbesartan 300mg Tablets, 90 Count Bottle B162009 Sep-19 B162010 Sep-19 B162011 Sep-19 B162012 Nov-19 B162013 Nov-19 B162014 Nov-19 B162015 Nov-19 C162001 Feb-20
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-0272-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 29, 2018
- FDA report date
- Nov 28, 2018
- Quantity
- 30,194 HDPE bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sciegen Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0272-2019, 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
- 60429-642-30 Irbesartan 300mg Tablets, 30 Count Bottle GS019036 Sep-19 GS019073 Sep-19 GS021472 Nov-19 GS021530 Nov-19 GS022234 Feb-20 60429-642-90 Irbesartan 300mg Tablets, 90 Count Bottle B162009 Sep-19 B162010 Sep-19 B162011 Sep-19 B162012 Nov-19 B162013 Nov-19 B162014 Nov-19 B162015 Nov-19 C162001 Feb-20
- Postal code
- 11788-3727
- Report date
- Nov 28, 2018
- Product type
- Drugs
- Recall number
- D-0272-2019
- Classification
- Class II
- Recalling firm
- Sciegen Pharmaceuticals Inc
- Product quantity
- 30,194 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, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 29, 2018
- Initial firm notification
- Press Release
- Center classification date
- Nov 20, 2018