The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0307-2020·Announced 2019-11-20

GSMS Recalls Ranitidine Capsules Due to NDMA Impurity Detection

Golden State Medical Supply Inc. is recalling specific lots of Ranitidine Capsules 150 mg because the FDA detected the NDMA impurity in the product.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves the detection of NDMA, a known carcinogenic impurity, which aligns with the rubric criteria for Severe severity.

Plain-English summary

Golden State Medical Supply Inc. is recalling specific lots of Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05). The product was manufactured by Novitium Pharma LLC and packaged by GSMS, Incorporated. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product.

The affected lots are GS023970, GS026108, GS026099, GS026838, GS025702, GS027272, and GS027273. Most of these lots have an expiration date of 10/31/2020, while lot GS027273 expires on 05/31/2021. The FDA has classified this recall as Class II.

The product was distributed in Arizona, Iowa, Massachusetts, and Missouri. Patients and healthcare providers should stop using the affected lots and contact their healthcare provider for guidance on alternative treatments or replacements.

The recalled product

Product
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.
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Lot Codes: GS023970
  • Exp. 10/31/2020
  • GS026108
  • GS026099
  • GS026838
  • GS025702
  • GS027272
  • GS027273
  • Exp. 05/31/2021.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 2 recalled by Golden State Medical Supply Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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