The Recall Desk
SevereFDA (Drugs)·D-0308-2020·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 300 mg because the FDA detected the NDMA impurity in the product.

What this means for you

Illness, injury, or structural failure has been reported. 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 the presence of the NDMA impurity in a pharmaceutical product represents a significant health risk, meeting the criteria for a Severe rating.

Plain-English summary

Golden State Medical Supply Inc. is recalling specific lots of Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01). The product was manufactured by Novitium Pharma LLC and packaged by GSMS, Incorporated. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product.

The affected lots are distributed in Arizona, Iowa, Massachusetts, and Missouri. The specific lot codes and expiration dates are: 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), and GS027554 (Exp. 05/31/2021).

Consumers and healthcare providers should check their inventory for these specific lot codes and expiration dates. If the product matches the recalled description, it should be discontinued and returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

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.
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 (18)

  • Lot Codes: GS023971
  • Exp. 10/31/2020
  • GS025527
  • GS025526
  • GS026114
  • GS025813
  • GS026189
  • Exp. 10/31/2021
  • GS027555
  • Exp. 7/31/2021
  • GS026190
  • Exp. 5/31/2021
  • GS026220
  • Exp. 05/31/2021
  • GS026584
  • GS027139
  • GS027554
  • 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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