PD-Rx Pharmaceuticals, Inc.: 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: 43063-902-60

Is my product affected?

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: 43063-902-60

• 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 750 mg tablets in both 30-tablet and 60-tablet bottles due to the detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable levels. The affected products were distributed across 16 states including California, Florida, New York, and others, with a total of 125 bottles recalled across multiple lot numbers with expiration dates ranging from January 2021 through March 2022.

The source document does not specify what actions affected consumers should take in response to this recall.

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: 125 bottles Lot/code info: Lots: a) A20A97, B20D25 Exp. 04/30/21, B20D69, C20B95, C20D60, E20A50 Exp. 07/31/21, E20D37, E20D73 Exp. 03/31/22, J19F04 Exp. 01/31/21; b) C20C15 Exp. 07/31/21, F20A14 Exp. 03/31/22, L19C15 Exp. 04/30/21

Source

Official record: FDA (Drug enforcement) ↗

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

Related recalls

• 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 731272020-10-06
• 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