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Class II: temporary or reversible health riskOngoing

Amneal Pharmaceuticals Ranitidine Tablets Recall

Ranitidine Tablets, USP 150 mg, 1000-count bottles

Amneal Pharmaceuticals, Inc. · Brookhaven, NY

Risk level
Class II
Reported by FDA
Dec 18, 2019
Recall ID
D-0615-2020
Check your lot numberHow we source this data

Summary

Amneal Pharmaceuticals recalled Ranitidine Tablets starting Nov 22, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0615-2020 on Dec 18, 2019. Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. Status: Ongoing.

Why it was recalled

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Product description

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

Lot numbers, UPCs & expiration codes

HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4/2021

Where it was sold

Product was distributed throughout the United States.

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-0615-2020
Classification
Class II
Status
Ongoing
Recall initiated
Nov 22, 2019
FDA report date
Dec 18, 2019
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Amneal Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0615-2020, exactly as published.

Show all FDA fields
City
Brookhaven
State
NY
Status
Ongoing
Country
United States
Event ID
84353
Address
50 Horseblock Rd
Code information
HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4/2021
Postal code
11719-9509
Report date
Dec 18, 2019
Product type
Drugs
Recall number
D-0615-2020
Classification
Class II
Recalling firm
Amneal Pharmaceuticals, Inc.
Reason for recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Voluntary / mandated
Voluntary: Firm initiated
Product description
Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
Distribution pattern
Product was distributed throughout the United States.
Recall initiation date
Nov 22, 2019
Initial firm notification
Press Release
Center classification date
Dec 9, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0615-2020, published Dec 18, 2019. 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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