The Recall Desk
SevereFDA (Drugs)·D-0794-2020·Announced 2020-01-29

Denton Pharma Recalls Ranitidine Tablets Due to NDMA Impurity

Denton Pharma is recalling 1,341 bottles of Ranitidine Tablets 150 mg because the product was found to contain the NDMA impurity.

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 involves the detection of NDMA, a known carcinogenic impurity, which meets the rubric criteria for a Severe rating.

Plain-English summary

Denton Pharma, Inc. is recalling 1,341 bottles of Ranitidine Tablets, USP 150 mg. The affected products are available in 4-count, 20-count, 24-count, 30-count, and 90-count bottles and were repackaged by Northwind Pharmaceuticals. The recall is classified as FDA Class II.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The affected units were distributed nationwide.

Consumers with these products should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatments. The specific lot codes and expiration dates for the recalled bottles are listed in the official recall notice.

The recalled product

Product
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals
Manufacturer
Denton Pharma, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
1,341

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 (15)

  • a). N102851902
  • Exp. 04/30/2021 b). D102851801
  • Exp. 04/2021 c). N102851901
  • Exp. 11/30/2021 N102851903
  • Exp. 12/31/2021 N102851906
  • Exp. 03/31/2022 d). N102851904
  • Exp. 02/28/2022 N102851905
  • Exp. 12/31/2021 e). C102851901
  • Exp. 11/30/2021 C102851902
  • Exp. 11/30/2021 C102851903
  • Exp. 11/30/2021 C102851904
  • Exp. 05/31/2021 C102851905
  • Exp. 02/28/2022 C102851906
  • Exp. 02/28/2022 C102851907
  • Exp. 03/31/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Denton Pharma, 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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