D-0308-2020 Class II Terminated
FDA drug recall D-0308-2020 was initiated by Golden State Medical Supply Inc. on Nov 6, 2019 and is designated Class II. Reason for recall: CGMP Deviations: Presence of NDMA impurity detected in product. The recall status is terminated (terminated Apr 15, 2021).
Recall details
- Product Type
- Drugs
- Report Date
- Nov 20, 2019
- Initiation Date
- Nov 6, 2019
- Termination Date
- Apr 15, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
Product 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.
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution pattern
AZ, IA, MA, MO
Code information
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0308-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026