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Class II: temporary or reversible health riskOngoing

amneal Metformin Hydrochloride Recall

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 coun…

Amneal Pharmaceuticals of New York, LLC · Brookhaven, NY

Risk level
Class II
Reported by FDA
Jul 1, 2020
Recall ID
D-1343-2020
Check your lot numberHow we source this data

Summary

Amneal Pharmaceuticals of New York recalled amneal Metformin Hydrochloride starting May 29, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1343-2020 on Jul 1, 2020. Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. Status: Ongoing.

Why it was recalled

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Product description

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01

Lot numbers, UPCs & expiration codes

HA07419A 1/31/2021 HB00119A 1/31/2021 HB00219A 1/31/2021 HB00319A 1/31/2021; HB00419A 2/28/2021 HB00519A 2/28/2021 HB00619A 2/28/2021 HB00719A 2/28/2021 HB00819A 2/28/2021 HB00919A 2/28/2021 HB01019A 2/28/2021 HB05119A 2/28/2021 HB05219A 2/28/2021 HB05319A 2/28/2021 HB05419A 2/28/2021 HB05519A 2/28/2021 HB09519A 2/28/2021 HB09619A 2/28/2021 HB09719A 2/28/2021 HB09819A 2/28/2021 HB09919A 2/28/2021; HC08219A 3/31/2021 HC08319A 3/31/2021 HC08419A 3/31/2021 HC08519A 3/31/2021 HC09019A 3/31/2021 HC09119A 3/31/2021 HC09219A 3/31/2021 HC09319A 3/31/2021 HC09419A 3/31/2021; HD03419B 4/30/2021 HD03519B 4/30/2021 HD03619B 4/30/2021 HD03719B 4/30/2021 HD03819B 4/30/2021 HD03919B 4/30/2021 HD04019B 4/30/2021 HD04119B 4/30/2021 HD04219A 4/30/2021 HD05819A 4/30/2021 HD05919A 4/30/2021 HD06019A 4/30/2021 HD06119A 4/30/2021 HD06219A 4/30/2021 HD06319A 4/30/2021 HD06419A 4/30/2021 HD09019A 4/30/2021 HD09119A 4/30/2021 HD09219A 4/30/2021 HE01219B 4/30/2021 HE01319B 4/30/2021 HE01419B 4/30/2021 HE01519B 4/30/2021; HE01619A 5/31/2021 HE01719A 5/31/2021 HE01819A 5/31/2021 HE04419A 5/31/2021 HE04519A 5/31/2021 HE04619A 5/31/2021 HE04719A 5/31/2021 HE04819A 5/31/2021 HE04919A 5/31/2021 HE05019A 5/31/2021 HE05119A 5/31/2021 HE05219A 5/31/2021 HE05319A 5/31/2021 HE07219A 5/31/2021 HE07319A 5/31/2021 HE07419A 5/31/2021 HE07519A 5/31/2021 HE07619A 5/31/2021 HF02219A 5/31/2021 HF02319A 5/31/2021; HF02419A 6/30/2021 HF02519A 6/30/2021 HF02619A 6/30/2021 HF02719A 6/30/2021 HF02819A 6/30/2021 HF02919A 6/30/2021 HF03019A 6/30/2021 HF03119A 6/30/2021 HF03219A 6/30/2021 HF03319A 6/30/2021 HF05419A 6/30/2021; HF03918A 6/30/2020 HF04018A 6/30/2020 HF04118A 6/30/2020 HF04218A 6/30/2020 HF04318A 6/30/2020 HF04418A 6/30/2020 HF06518A 6/30/2020 HF06818B 6/30/2020 HF06918B 6/30/2020 HF07018B 6/30/2020 HF07118B 6/30/2020 HF07218A 6/30/2020 HF07318A 6/30/2020 HF07418A 6/30/2020 HF08318A 6/30/2020 HF08418A 6/30/2020 HF08518A 6/30/2020; HF11219A 6/30/2021 HF11319A 6/30/2021 HF11419A 6/30/2021 HF11519A 6/30/2021 HF11619A 6/30/2021 HF11719A 6/30/2021 HF11819A 6/30/2021 HF11919A 6/30/2021 HF12019A 6/30/2021 HG00719A 6/30/2021 HG00819A 6/30/2021 HG00919A 6/30/2021 HG01019A 6/30/2021 HG01119A 6/30/2021 HG01219A 6/30/2021 HG01319A 6/30/2021 HG01419A 6/30/2021; HG01519A 7/31/2021 HG01619A 7/31/2021 HG02919A 7/31/2021 HG03019A 7/31/2021 HG03119A 7/31/2021 HG03219A 7/31/2021 HG03319A 7/31/2021 HG03419A 7/31/2021 HG03519A 7/31/2021 HG03619A 7/31/2021 HG03719A 7/31/2021 HG03819A 7/31/2021; HH08218A 8/31/2020 HH08318A 8/31/2020 HH08418A 8/31/2020 HH08518A 8/31/2020 HH08618A 8/31/2020 HH08718A 8/31/2020 HH08818A 8/31/2020 HH08918A 8/31/2020 HH09018A 8/31/2020 HH09118A 8/31/2020 HH09218A 8/31/2020 HH09318A 8/31/2020 HH09418A 8/31/2020 HH09518A 8/31/2020 HH09618A 8/31/2020 HH11218A 8/31/2020 HH11318A 8/31/2020 HH11418A 8/31/2020 HH11518A 8/31/2020; HH11618A 9/30/2020 HH11718A 9/30/2020 HJ04818A 9/30/2020 HJ04918A 9/30/2020 HJ08518A 9/30/2020; HJ08618A 10/31/2020 HJ08718A 10/31/2020 HJ08818A 10/31/2020 HJ08918A 10/31/2020 HJ09018A 10/31/2020 HJ09118A 10/31/2020 HK03718A 10/31/2020 HK03818A 10/31/2020 HK03918A 10/31/2020 HK04018A 10/31/2020 HK04118A 10/31/2020 HK04218A 10/31/2020 HK04318A 10/31/2020 HK04418A 10/31/2020 HK04518A 10/31/2020 HK04618A 10/31/2020 HK09318A 10/31/2020 HK09418A 10/31/2020 HK09518A 10/31/2020 HK09618A 10/31/2020 HK09718A 10/31/2020; HM00218A 12/31/2020 HM00318A 12/31/2020 HM00418A 12/31/2020 HM00518A 12/31/2020 HM00618B 12/31/2020 HM00718B 12/31/2020 HM00818B 12/31/2020 HM00918B 12/31/2020 HM01018B 12/31/2020; HM02918A 1/31/2021 HM03018A 1/31/2021 HM03218A 1/31/2021 HM03318A 1/31/2021 HM03418A 1/31/2021 HM03518A 1/31/2021 HM03618A 1/31/2021 HM03718A 1/31/2021 HM03818A 1/31/2021

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-1343-2020
Classification
Class II
Status
Ongoing
Recall initiated
May 29, 2020
FDA report date
Jul 1, 2020
Quantity
192
Recall type
Voluntary: Firm initiated
Recalling firm
Amneal Pharmaceuticals of New York, LLC

Original FDA data

Every field from FDA enforcement report D-1343-2020, exactly as published.

Show all FDA fields
City
Brookhaven
State
NY
Status
Ongoing
Country
United States
Event ID
85781
Address
50 Horseblock Rd
Code information
HA07419A 1/31/2021 HB00119A 1/31/2021 HB00219A 1/31/2021 HB00319A 1/31/2021; HB00419A 2/28/2021 HB00519A 2/28/2021 HB00619A 2/28/2021 HB00719A 2/28/2021 HB00819A 2/28/2021 HB00919A 2/28/2021 HB01019A 2/28/2021 HB05119A 2/28/2021 HB05219A 2/28/2021 HB05319A 2/28/2021 HB05419A 2/28/2021 HB05519A 2/28/2021 HB09519A 2/28/2021 HB09619A 2/28/2021 HB09719A 2/28/2021 HB09819A 2/28/2021 HB09919A 2/28/2021; HC08219A 3/31/2021 HC08319A 3/31/2021 HC08419A 3/31/2021 HC08519A 3/31/2021 HC09019A 3/31/2021 HC09119A 3/31/2021 HC09219A 3/31/2021 HC09319A 3/31/2021 HC09419A 3/31/2021; HD03419B 4/30/2021 HD03519B 4/30/2021 HD03619B 4/30/2021 HD03719B 4/30/2021 HD03819B 4/30/2021 HD03919B 4/30/2021 HD04019B 4/30/2021 HD04119B 4/30/2021 HD04219A 4/30/2021 HD05819A 4/30/2021 HD05919A 4/30/2021 HD06019A 4/30/2021 HD06119A 4/30/2021 HD06219A 4/30/2021 HD06319A 4/30/2021 HD06419A 4/30/2021 HD09019A 4/30/2021 HD09119A 4/30/2021 HD09219A 4/30/2021 HE01219B 4/30/2021 HE01319B 4/30/2021 HE01419B 4/30/2021 HE01519B 4/30/2021; HE01619A 5/31/2021 HE01719A 5/31/2021 HE01819A 5/31/2021 HE04419A 5/31/2021 HE04519A 5/31/2021 HE04619A 5/31/2021 HE04719A 5/31/2021 HE04819A 5/31/2021 HE04919A 5/31/2021 HE05019A 5/31/2021 HE05119A 5/31/2021 HE05219A 5/31/2021 HE05319A 5/31/2021 HE07219A 5/31/2021 HE07319A 5/31/2021 HE07419A 5/31/2021 HE07519A 5/31/2021 HE07619A 5/31/2021 HF02219A 5/31/2021 HF02319A 5/31/2021; HF02419A 6/30/2021 HF02519A 6/30/2021 HF02619A 6/30/2021 HF02719A 6/30/2021 HF02819A 6/30/2021 HF02919A 6/30/2021 HF03019A 6/30/2021 HF03119A 6/30/2021 HF03219A 6/30/2021 HF03319A 6/30/2021 HF05419A 6/30/2021; HF03918A 6/30/2020 HF04018A 6/30/2020 HF04118A 6/30/2020 HF04218A 6/30/2020 HF04318A 6/30/2020 HF04418A 6/30/2020 HF06518A 6/30/2020 HF06818B 6/30/2020 HF06918B 6/30/2020 HF07018B 6/30/2020 HF07118B 6/30/2020 HF07218A 6/30/2020 HF07318A 6/30/2020 HF07418A 6/30/2020 HF08318A 6/30/2020 HF08418A 6/30/2020 HF08518A 6/30/2020; HF11219A 6/30/2021 HF11319A 6/30/2021 HF11419A 6/30/2021 HF11519A 6/30/2021 HF11619A 6/30/2021 HF11719A 6/30/2021 HF11819A 6/30/2021 HF11919A 6/30/2021 HF12019A 6/30/2021 HG00719A 6/30/2021 HG00819A 6/30/2021 HG00919A 6/30/2021 HG01019A 6/30/2021 HG01119A 6/30/2021 HG01219A 6/30/2021 HG01319A 6/30/2021 HG01419A 6/30/2021; HG01519A 7/31/2021 HG01619A 7/31/2021 HG02919A 7/31/2021 HG03019A 7/31/2021 HG03119A 7/31/2021 HG03219A 7/31/2021 HG03319A 7/31/2021 HG03419A 7/31/2021 HG03519A 7/31/2021 HG03619A 7/31/2021 HG03719A 7/31/2021 HG03819A 7/31/2021; HH08218A 8/31/2020 HH08318A 8/31/2020 HH08418A 8/31/2020 HH08518A 8/31/2020 HH08618A 8/31/2020 HH08718A 8/31/2020 HH08818A 8/31/2020 HH08918A 8/31/2020 HH09018A 8/31/2020 HH09118A 8/31/2020 HH09218A 8/31/2020 HH09318A 8/31/2020 HH09418A 8/31/2020 HH09518A 8/31/2020 HH09618A 8/31/2020 HH11218A 8/31/2020 HH11318A 8/31/2020 HH11418A 8/31/2020 HH11518A 8/31/2020; HH11618A 9/30/2020 HH11718A 9/30/2020 HJ04818A 9/30/2020 HJ04918A 9/30/2020 HJ08518A 9/30/2020; HJ08618A 10/31/2020 HJ08718A 10/31/2020 HJ08818A 10/31/2020 HJ08918A 10/31/2020 HJ09018A 10/31/2020 HJ09118A 10/31/2020 HK03718A 10/31/2020 HK03818A 10/31/2020 HK03918A 10/31/2020 HK04018A 10/31/2020 HK04118A 10/31/2020 HK04218A 10/31/2020 HK04318A 10/31/2020 HK04418A 10/31/2020 HK04518A 10/31/2020 HK04618A 10/31/2020 HK09318A 10/31/2020 HK09418A 10/31/2020 HK09518A 10/31/2020 HK09618A 10/31/2020 HK09718A 10/31/2020; HM00218A 12/31/2020 HM00318A 12/31/2020 HM00418A 12/31/2020 HM00518A 12/31/2020 HM00618B 12/31/2020 HM00718B 12/31/2020 HM00818B 12/31/2020 HM00918B 12/31/2020 HM01018B 12/31/2020; HM02918A 1/31/2021 HM03018A 1/31/2021 HM03218A 1/31/2021 HM03318A 1/31/2021 HM03418A 1/31/2021 HM03518A 1/31/2021 HM03618A 1/31/2021 HM03718A 1/31/2021 HM03818A 1/31/2021
Postal code
11719-9509
Report date
Jul 1, 2020
Product type
Drugs
Recall number
D-1343-2020
Classification
Class II
Recalling firm
Amneal Pharmaceuticals of New York, LLC
Product quantity
192
Reason for recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Voluntary / mandated
Voluntary: Firm initiated
Product description
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01
Distribution pattern
Nationwide
Recall initiation date
May 29, 2020
Initial firm notification
Press Release
Center classification date
Jun 25, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1343-2020, published Jul 1, 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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