Recall: D-1253-2020

Class II - Potentially Harmful

Class IIClassification

2020-04-15Initiated

TerminatedStatus

Amneal Pharmaceuticals of New Firm

Product

Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15

Reason

CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.