Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478

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

Code information: Lots: a) 23069 Exp. 11/30/2020, 24571 Exp. 05/31/2021, 25310 Exp. 07/31/2021, 26391 Exp. 01/31/2022; b) 22542 Exp. 06/30/2020, 23345 Exp. 11/30/2020, 24032 Exp. 03/31/2021, 24624 Exp. 07/31/2021, 24631 Exp. 05/31/2021, 25381 Exp. 08/31/2021, 25907 Exp. 10/31/2021, 26478 Exp. 01/31/2022; c) 22348 Exp. 06/30/2020, 22405 Exp. 06/30/2020, 22406 Exp. 06/30/2020, 22740 Exp. 06/30/2020, 23346 Exp. 11/30/2020, 23926 Exp. 03/31/2021, 24364 Exp. 05/31/2021, 25014 Exp. 07/31/2021, 25334 Exp. 09/30/2021, 25906 Exp. 10/31/2021, 26392 Exp. 01/31/2022

Distribution pattern: Nationwide.