The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0792-2020·Announced 2020-01-29

Mylan Recalls Nizatidine Capsules Due to NDMA Impurity Detection

Mylan Pharmaceuticals is recalling Nizatidine Capsules 300 mg because trace amounts of the impurity NDMA were detected in the active ingredient.

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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant health risks or potential for serious injury are categorized as Severe (Score 4), particularly when specific impurities like NDMA are involved.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Nizatidine Capsules, USP 300 mg, Rx Only (NDC 0378-5300-93). The recall involves 16,944 bottles of 30 capsules from Lot # 3082876 and Lot # 3082877, both with an expiration date of January 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 contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
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 (3)

  • Lot # 3082876
  • exp. date January 2020 Lot # 3082877
  • exp. date January 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

Same manufacturer · Mylan Pharmaceuticals Inc.

See all →

Same hazard · ndma impurity

See all →

Similar recalls