GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Codes: GS023971, Exp. 10/31/2020; GS025527, Exp. 10/31/2020; GS025526, Exp. 10/31/2020; GS026114, Exp. 10/31/2020; GS025813, Exp. 10/31/2020; GS026189, Exp. 10/31/2021; GS027555, Exp. 7/31/2021; GS026190, Exp. 5/31/2021; GS026220, Exp. 05/31/2021; GS026584, Exp. 05/31/2021; GS027139, Exp. 05/31/2021; GS027554, Exp. 05/31/2021.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Golden State Medical Supply Inc.
- Reason for Recall:
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
Product Codes/Lot Numbers:
Lot Codes: GS023971, Exp. 10/31/2020; GS025527, Exp. 10/31/2020; GS025526, Exp. 10/31/2020; GS026114, Exp. 10/31/2020; GS025813, Exp. 10/31/2020; GS026189, Exp. 10/31/2021; GS027555, Exp. 7/31/2021; GS026190, Exp. 5/31/2021; GS026220, Exp. 05/31/2021; GS026584, Exp. 05/31/2021; GS027139, Exp. 05/31/2021; GS027554, Exp. 05/31/2021.
Distribution:
Distributed in: AZ, IA, MA, MO
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0308-2020
Related Recalls
Failed Dissolution Specifications
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30
Golden State Medical Supply
Failed Dissolution Specifications
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.