FDA Recall D-1350-2020

Amneal Pharmaceuticals of New York, LLC · Brookhaven, NY

Class II Ongoing 2176 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK

Lot / code: HA01320A 1/31/2021 HA01420A 1/31/2021 HA06820A 1/31/2021 HB03620A 1/31/2021 HB03720A 1/31/2021 HB03820A 1/31/2021 HB03920A 1/31/2021 HB04020A 1/31/2021 HB04120A 1/31/2021 HB04220A 1/31/2021 HB04320A 2/28/2021 HB04420A 1/31/2021 HB04520A 2/28/2021 HB05020A 2/28/2021 HB05120A 2/28/2021 HB05220A 2/28/2021 HB05320A 2/28/2021 HB05420A 2/28/2021 HB05520A 2/28/2021 HB05620A 2/28/2021 HB07020A 2/28/2021 HB07120A 2/28/2021 HB07220A 2/28/2021 HB07320A 2/28/2021 HB07520A 2/28/2021 HB07620A 2/28/2021 HB07720A 2/28/2021 HB07820A 2/28/2021 HB07920A 2/28/2021 HB08020A 2/28/2021 HB08220A 2/28/2021 HF05519A 6/30/2020 HF05619A 6/30/2020 HF05719A 6/30/2020 HF05819A 6/30/2020 HF05919A 6/30/2020 HF06019A 6/30/2020 HF06119A 6/30/2020 HF06219A 6/30/2020 HF06319A 6/30/2020 HF07719A 6/30/2020 HF07819A 6/30/2020 HF07919A 6/30/2020 HF08019A 6/30/2020 HF08119A 6/30/2020 HF08219A 6/30/2020 HF08319A 6/30/2020 HF08419A 6/30/2020 HF08519A 6/30/2020 HF08619A 6/30/2020 HF10119A 6/30/2020 HF10219A 6/30/2020 HF10319A 6/30/2020 HF10419A 6/30/2020 HF10519A 6/30/2020 HF10619A 6/30/2020 HF10719A 6/30/2020 HF10819A 6/30/2020 HF10919A 6/30/2020 HF11019A 6/30/2020 HF11119A 6/30/2020 HG07219A 7/31/2020 HG07319A 7/31/2020 HG07419A 7/31/2020 HG07519A 7/31/2020 HG07619A 7/31/2020 HG07719A 7/31/2020 HG07819A 7/31/2020 HG07919A 7/31/2020 HG08019A 7/31/2020 HG08119A 7/31/2020 HH00619A 7/31/2020 HH00719A 7/31/2020 HH00819A 7/31/2020 HH00919A 7/31/2020 HH01019A 7/31/2020 HH01119A 8/31/2020 HH01219A 8/31/2020 HH01319A 8/31/2020 HH01419A 8/31/2020 HH01519A 8/31/2020 HH07319A 8/31/2020 HH07419A 8/31/2020 HH07519A 8/31/2020 HH07619A 8/31/2020 HH07719A 8/31/2020 HH07819A 8/31/2020 HH07919A 8/31/2020 HH08019A 8/31/2020 HH08119A 8/31/2020 HH08219A 8/31/2020 HH11119A 10/31/2020 HH11219A 10/31/2020 HH11319A 10/31/2020 HH11419A 10/31/2020 HH11519A 10/31/2020 HH11619A 10/31/2020 HH11719A 10/31/2020 HH11819A 10/31/2020 HH11919A 10/31/2020 HH12019A 10/31/2020 HH12119A 10/31/2020 HH12219A 10/31/2020 HH12319A 10/31/2020 HH12419A 10/31/2020 HH12519A 10/31/2020 HH12619A 10/31/2020 HH12719A 10/31/2020 HH12819A 10/31/2020 HH12919A 10/31/2020 HH13019A 10/31/2020 HL00119A 10/31/2020 HL00219A 11/30/2020 HL00319A 11/30/2020 HL00419A 11/30/2020 HL00519A 11/30/2020 HL00619A 11/30/2020 HL00719A 11/30/2020 HL00819A 11/30/2020 HL00919A 11/30/2020 HL01019A 11/30/2020

Quantity: N/A

Reason for recall

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

Recall record

Recall number: D-1350-2020
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide
Recall initiated: 2020-05-29
Classified by FDA Center: 2020-06-25
FDA published: 2020-07-01
Recalling firm: Amneal Pharmaceuticals of New York, LLC
Firm location: Brookhaven, NY

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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