AVKARE 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

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

Code information: Lots: 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

Distribution pattern: Nationwide.