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); e) 100 ta

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); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only 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 five different package sizes (30, 60, 90, 180, and 100 tablets) distributed in the United States. The recall was initiated because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels in the product, which represents a current good manufacturing practice (CGMP) deviation.

A total of 1,969 bottles are affected across multiple lot codes with expiration dates of 08/21/2020 and 12/31/2020. The source document does not specify what action consumers should take regarding this recall.

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

Hazard

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

Details from the source

Reason for recall: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Distribution: United States. Quantity: 1969 bottles Lot/code info: Lots: a) A20B02, I19D03, J19A98, K19E32, L19C86 Exp. 12/31/2020; b) I19D55, I19F50, K19A18, K19D87, L19B34, L19D23, L19E74 Exp. 12/31/2020; c) I19E91, I19F33, J19B88, J19E70, K19D26, L19A65 Exp. 12/31/2020; d) I19C21 Exp. 08/21/2020, I19C57, J19C21, J19C67, K19B53, L19C77, L19E44 Exp. 12/31/2020; e) XP9004 Exp. 12/31/2020

Source

Official record: FDA (Drug enforcement) ↗

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

Related recalls

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• 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
• 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
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All FDA (Drug enforcement) recalls