PD-Rx Pharmaceuticals, Inc.: metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx on

Is my product affected?

metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

• Brand METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Check against the official notice below — it lists the full affected range.

What happened

PD-Rx Pharmaceuticals, Inc. is recalling metformin HCL ER 500 mg tablets in four bottle sizes (30, 60, 90, and 180 tablets) due to the detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels. The affected products were distributed across 16 states: Alaska, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Minnesota, North Carolina, New York, Oklahoma, Oregon, and Wisconsin. A total of 1,683 bottles are involved in the recall, with specific lot numbers and expiration dates ranging from July 31, 2021 to April 30, 2022.

The recall affects prescription metformin products with the following National Drug Codes: 72789-009-30 (30 tablets), 72789-009-60 (60 tablets), 72789-009-90 (90 tablets), and 72789-009-93 (180 tablets). The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Details from the source

Reason for recall: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) Distribution: AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI Quantity: 1683 bottles Lot/code info: Lots: a) B20D23, B20D67 Exp. 07/31/21, C20D55 Exp. 12/31/21; b) A20D92, A20F59, B20C16 Exp. 07/31/21, C20D63, D20A45, D20C80 Exp. 12/31/21, G20D46, I20C57 Exp. 04/30/22; c) A20D90, A20E77, A20F69, B20F43 Exp. 07/31/21, C20B14, D20A41 Exp. 12/31/21, I20D94, I20E56, J20A28 Exp. 04/30/22; d) B20B96 Exp. 07/31/21, C20C28, C20E58, D20B17 Exp. 12/31/21, G20D91 Exp. 04/30/22

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-602020-10-06
• Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 1172020-10-02
• Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 4942020-10-02
• metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 731272020-06-05
• Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Pharma Drive, Morrisville, NC 27560, Distributed by: Perrigo, Allegan, MI 49010 NDC 45802-088-012020-09-16

All FDA (Drug enforcement) recalls