Class II · ModerateRecall completed
GSMS: Ranitidine Capsules 150 mg
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot 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 soldAZ, IA, MA, MO
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Presence of NDMA impurity detected in product.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byNovitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA
| Distributed by / for | Golden State Medical Supply Inc. |
| NDC | 51407-097-05 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Golden State Medical Supply Inc. |
| Distribution | AZ, IA, MA, MO |
| Quantity | N/A |
| Recall initiated | 2019-11-06 |
| Report date | 2019-11-20 |
| Recall completed | 2021-04-15 |
| Recall number | D-0307-2020 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Camarillo CA United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.