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
Reported: May 6, 2020 Initiated: April 15, 2020 #D-1253-2020
Product Description
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 for Recall
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Details
- Recalling Firm
- Amneal Pharmaceuticals of New York, LLC
- Units Affected
- 11258 bottles
- Distribution
- Nationwide
- Location
- Brookhaven, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amneal Pharmaceuticals of New York, LLC. Units affected: 11258 bottles.
Why was this product recalled? ▼
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 6, 2020. Severity: Moderate. Recall number: D-1253-2020.
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