Agency classClass IIOur severity:Severe FDA (Drugs)·D-0640-2020·Announced 2020-01-15

Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

Glenmark Pharmaceuticals is recalling 217,956 bottles of Ranitidine Tablets USP 150 mg nationwide because the product contains the NDMA impurity.

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. According to the severity rubric, an FDA Class II recall with significant injury/property-damage reports or structural defects is rated as Severe (4). While the source text does not explicitly list hospitalizations, the presence of NDMA (a probable human carcinogen) in a Class II drug recall aligns with the 'Severe' criteria for significant health risks.

Plain-English summary

Glenmark Pharmaceuticals Inc. is recalling 217,956 bottles of Glenmark Ranitidine Tablets USP 150 mg, 100-count bottles. The product is distributed nationwide. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product.

The affected product is identified by the NDC 68462-248-01. Specific lot codes associated with the recall include 7701033A, 7701826A, 7702344A, 7702345A, 7702489A, 7702706A, 7702707A, 7702708A, 7702858A, 7702859A, 7702860A, 7702928A, 7702929A, 7703196A, 7703634A, 7704492A, 7704493A, 7705159A, 19190289, 19190342, and 19190372.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatments. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Category: Drug — Prescription Medication
Hazard: ndma-impurity
cgmp-deviation
Affected units: 217,956

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 recalled by Glenmark Pharmaceuticals Inc., USA 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 6 products in this recall →

Same manufacturer · Glenmark Pharmaceuticals Inc., USA

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