AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30

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

Code information: Lots: a) 21307 Exp. 02/29/2020, 21309 Exp. 02/29/2020, 21528 Exp. 02/29/2020, 21527 Exp. 02/29/2020, 22247 Exp. 06/30/2020, 23214 Exp. 09/30/2020, 23243 Exp. 09/30/2020, 23244 Exp. 11/30/2020, 24198 Exp. 01/31/2021, 24199 Exp. 01/31/2021, 24289 Exp. 01/31/2021; b) 22291 Exp. 06/30/2020, 23215 Exp. 09/30/2020, 23776 Exp. 01/31/2021

Distribution pattern: Nationwide.