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.
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 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
- 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.
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