Class II
Terminated
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.
This recall has been terminated (originally issued November 20, 2019).
- Company
- Golden State Medical Supply Inc.
- Recall Initiated
- November 6, 2019
- Posted
- November 20, 2019
- Recall Number
- D-0308-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Camarillo, CA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Distribution
AZ, IA, MA, MO
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.
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