Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Product description
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: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
Lot numbers, UPCs & expiration codes
Lot Numbers: 30-count bottles GS019036; Exp 09/19 GS019073; Exp. 09/19 GS021472; Exp. 11/19 GS021530; Exp. 11/19 GS022234; Exp. 02/20 90-count bottles B162009; Exp. 09/19 B162010; Exp. 09/19 B162011; Exp. 09/19 B162012; Exp. 11/19 B162013; Exp. 11/19 B162014; Exp. 11/19 B162015; Exp. 11/19 C162001; Exp. 02/20
Where it was sold
Product was distributed throughout the United States.
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-0265-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 2, 2018
- FDA report date
- Nov 28, 2018
- Quantity
- 12,502 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0265-2019, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 81500
- Address
- 5187 Camino Ruiz
- Code information
- Lot Numbers: 30-count bottles GS019036; Exp 09/19 GS019073; Exp. 09/19 GS021472; Exp. 11/19 GS021530; Exp. 11/19 GS022234; Exp. 02/20 90-count bottles B162009; Exp. 09/19 B162010; Exp. 09/19 B162011; Exp. 09/19 B162012; Exp. 11/19 B162013; Exp. 11/19 B162014; Exp. 11/19 B162015; Exp. 11/19 C162001; Exp. 02/20
- Postal code
- 93012-8601
- Report date
- Nov 28, 2018
- Product type
- Drugs
- Recall number
- D-0265-2019
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 12,502 bottles
- Termination date
- Sep 16, 2020
- Reason for recall
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Nov 2, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2018