Recalls / Class II
Class IID-0308-2020
Product
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.
- Affected lot / code info
- 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.
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- N/A
- Distribution pattern
- AZ, IA, MA, MO
Timeline
- Recall initiated
- 2019-11-06
- FDA classified
- 2019-11-10
- Posted by FDA
- 2019-11-20
- Terminated
- 2021-04-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0308-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.