The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0795-2020·Announced 2020-01-29

Denton Pharma Recalls Ranitidine Tablets Due to NDMA Impurity

Denton Pharma is recalling 467 bottles of Ranitidine Tablets 300 mg because of the presence of NDMA impurity. The affected products were distributed nationwide.

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 presence of NDMA, a known carcinogen, which aligns with the rubric criteria for Severe severity (FDA Class II with significant health risks).

Plain-English summary

Denton Pharma, Inc. is recalling 467 bottles of Ranitidine Tablets, USP 300 mg. The affected products are available in 15-count and 90-count bottles and were repackaged by Northwind Pharmaceuticals in North Brenheim, NY. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product.

The recalled products are identified by specific lot codes and expiration dates, including N106851901, N106851902, C106851901, C106851902, C106851903, C106851904, and C106851905. These products were distributed nationwide. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have these specific bottles of Ranitidine Tablets should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.

The recalled product

Product
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
Manufacturer
Denton Pharma, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
467

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 (3)

  • a). N106851901
  • Exp. 11/30/2021 N106851902
  • Exp. 10/31/2021 b). C106851901

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 →

Related recalls

Same manufacturer · Denton Pharma, Inc.

See all →

Same hazard · ndma impurity

See all →

Similar recalls