The Recall Desk
SevereFDA (Drugs)·D-0791-2020·Announced 2020-01-29

Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

Mylan Pharmaceuticals is recalling Nizatidine Capsules 150 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

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 agency classification is FDA Class II, and the presence of NDMA, a potential carcinogen, in a prescription drug constitutes a significant health risk warranting a Severe rating under the rubric for significant injury/property-damage reports or high-risk contamination.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Nizatidine Capsules, USP 150 mg, Rx Only (NDC 0378-5150-91). The recall involves 31,736 bottles of 60 capsules from Lot Number 3086746, which has an expiration date of May 2020.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, trace amounts of an impurity, N-nitrosodimethylamine (NDMA), were detected in the active pharmaceutical ingredient (API) Nizatidine.

The product was distributed to wholesalers, distributors, retail pharmacies, charitable organizations, and mail order pharmacies throughout the United States. The product may have been further distributed. Consumers and healthcare providers should stop using the affected product and consult their healthcare provider for alternatives.

The recalled product

Product
Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
Manufacturer
Mylan Pharmaceuticals 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 (2)

  • Lot Number: 3086746
  • exp. date May 2020

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Mylan Pharmaceuticals 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

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Same hazard · ndma impurity

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