metformin HCL ER 750 mg recall: Nitrosamine Impurity
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…
Why was metformin HCL ER 750 mg recalled?
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Quantity
- 125 bottles
- Distribution
- AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
- Recall date
- November 11, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)