Agency classClass IIOur severity:Severe FDA (Drugs)·D-1253-2020·Announced 2020-05-06

Amneal Recalls Nizatidine Oral Solution Due to Potential NDMA Contamination

Amneal Pharmaceuticals is recalling Nizatidine Oral Solution because it may contain N-Nitrosodimethylamine (NDMA) levels above FDA limits.

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, which corresponds to a Severe severity score under the rubric for significant injury/property-damage reports or high-risk contamination scenarios.

Plain-English summary

Amneal Pharmaceuticals of New York, LLC is recalling Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles. The product is distributed by Gemini Laboratories, LLC and carries the NDC 60846-301-15. The recall involves 11,258 bottles distributed nationwide.

The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product may contain potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. The affected lots have codes 06598004A (04/2020), 06599001A (12/2020), and 06599002A (12/2020).

Consumers and healthcare providers should check their inventory for these specific lot codes and NDC numbers. If the product is found, it should be discontinued and returned to the distributor or manufacturer for disposal.

The recalled product

Product: NIZATIDINE (NIZATIDINE)
Brand: NIZATIDINE
Manufacturer: Amneal Pharmaceuticals of New York, LLC
Category: Drug — Prescription Drug
Hazard: ndma-contamination
Affected units: 11,258

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 (1)

06598004A 04/2020 06599001A 12/2020 06599002A 12/2020

Distribution

Distributed nationwide across the United States.

Same manufacturer · Amneal Pharmaceuticals of New York, LLC

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Same hazard · ndma contamination