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Class II: temporary or reversible health riskTerminated

Amneal Pharmaceuticals of New York Nizatidine Oral Solution Recall

Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed…

Amneal Pharmaceuticals of New York, LLC · Brookhaven, NY

Risk level
Class II
Reported by FDA
May 6, 2020
Recall ID
D-1253-2020
Check your lot numberHow we source this data

Summary

Amneal Pharmaceuticals of New York recalled Nizatidine Oral Solution starting Apr 15, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1253-2020 on May 6, 2020. Reason: CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1253-2020
Classification
Class II
Status
Terminated
Recall initiated
Apr 15, 2020
FDA report date
May 6, 2020
Quantity
11258 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Amneal Pharmaceuticals of New York, LLC

Original FDA data

Every field from FDA enforcement report D-1253-2020, exactly as published.

Show all FDA fields
City
Brookhaven
State
NY
Status
Terminated
Country
United States
Event ID
85386
Address
50 Horseblock Rd
Code information
06598004A 04/2020 06599001A 12/2020 06599002A 12/2020
Postal code
11719-9509
Report date
May 6, 2020
Product type
Drugs
Recall number
D-1253-2020
Classification
Class II
Recalling firm
Amneal Pharmaceuticals of New York, LLC
Product quantity
11258 bottles
Termination date
Sep 8, 2021
Reason for recall
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Apr 15, 2020
Initial firm notification
Press Release
Center classification date
Apr 24, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1253-2020, published May 6, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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