Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Product description
GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
Lot numbers, UPCs & expiration codes
Lot Codes: GS023970, Exp. 10/31/2020; GS026108, Exp. 10/31/2020;GS026099, Exp. 10/31/2020; GS026838, Exp. 10/31/2020; GS025702, Exp. 10/31/2020; GS027272, Exp. 10/31/2020; GS027273, Exp. 05/31/2021.
Where it was sold
AZ, IA, MA, MO
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-0307-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 6, 2019
- FDA report date
- Nov 20, 2019
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0307-2020, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 84233
- Address
- 5187 Camino Ruiz
- Code information
- Lot Codes: GS023970, Exp. 10/31/2020; GS026108, Exp. 10/31/2020;GS026099, Exp. 10/31/2020; GS026838, Exp. 10/31/2020; GS025702, Exp. 10/31/2020; GS027272, Exp. 10/31/2020; GS027273, Exp. 05/31/2021.
- Postal code
- 93012-8601
- Report date
- Nov 20, 2019
- Product type
- Drugs
- Recall number
- D-0307-2020
- Classification
- Class II
- Recalling firm
- Golden State Medical Supply Inc.
- Termination date
- Apr 15, 2021
- Reason for recall
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
- Distribution pattern
- AZ, IA, MA, MO
- Recall initiation date
- Nov 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 10, 2019