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Class II · ModerateRecall completed

AVKARE Ranitidine Tablets

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots: a) HK16617A Exp. 11/30/2019, HL03917A Exp. 11/30/2019, HL04017A Exp. 11/30/2019, HM06017A Exp. 11/30/2019, HM06117A Exp. 11/30/2019, HB03518A Exp. 03/31/2020, HB03618A Exp. 03/31/2020, HC14018A Exp. 04/30/2020, HC14118A Exp. 04/30/2020, HC14218A Exp. 04/30/2020, HC14318A Exp. 04/30/2020, HC14418A Exp. 04/30/2020, HC14518A Exp. 05/31/2020, HH04518A Exp. 08/31/2020, HH04618A Exp. 08/31/2020, HH04718A Exp. 08/31/2020, HH04818A Exp. 08/31/2020, HH04918A Exp. 08/31/2020, HK02718A Exp. 10/31/2020, HK06918A Exp. 10/31/2020, HL07418A Exp. 11/30/2020, HL07518A Exp. 11/30/2020, HA00419A Exp. 12/31/2020, HA00519A Exp. 12/31/2020, HA02719A Exp. 12/31/2020, HA02819A Exp. 12/31/2020, HA2719A Exp. 12/31/2020, HC05019A Exp. 03/31/2021, HC05119A Exp. 03/31/2021, HC05911A Exp. 03/31/2021, HE03319A Exp. 04/30/2021, HE03419A Exp. 04/30/2021, HE05419A Exp. 04/30/2021, HG02319A Exp. 06/30/2021, HG02419A Exp. 06/30/2021, HG02619A Exp. 06/30/2021; b) 21570 Exp. 03/31/2020, 21571 Exp. 03/31/2020, 22190 Exp. 03/31/2020, 22192 Exp. 05/31/2020, 22497 Exp. 05/31/2020, 22620 Exp. 05/31/2020, 22999 Exp. 09/30/2020, 23000 Exp. 09/30/2020, 24158 Exp. 03/31/2021, 24159 Exp. 04/30/2021; c) 21241 Exp. 03/31/2020, 21680 Exp. 03/31/2020, 22193 Exp. 03/31/2020, 22657 Exp. 03/31/2020, 23001 Exp. 09/30/2020, 23002 Exp. 09/30/2020, 24157 Exp. 04/30/2021
Where it was soldNationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets
Distributed by / forAvKARE, Inc. Pulaski, TN 38478
NDC42291-724-10
Show the full FDA record
Full product labelAVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
Recalling firmAVKARE Inc.
DistributionNationwide.
Quantity631,138 bottles
Recall initiated2019-11-14
Report date2019-12-04
Recall completed2021-10-27
Recall numberD-0524-2020
ClassificationClass II
FDA statusTerminated
Origin on filePulaski TN United States

Related

Ranitidine recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.