Nizatidine Oral Solution recall: Nitrosamine Impurity
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
Why was Nizatidine Oral Solution recalled?
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
06598004A 04/2020 06599001A 12/2020 06599002A 12/2020
- 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
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Quantity
- 11258 bottles
- Distribution
- Nationwide
- Recall date
- May 6, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)