Why it was recalled
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0059-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 6, 2020
- FDA report date
- Nov 11, 2020
- Quantity
- 1683 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0059-2021, exactly as published.
Show all FDA fields
- City
- Oklahoma City
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 86600
- Address
- 727 N Ann Arbor Ave
- Code information
- 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
- Postal code
- 73127-5822
- Report date
- Nov 11, 2020
- Product type
- Drugs
- Recall number
- D-0059-2021
- Classification
- Class II
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Product quantity
- 1683 bottles
- Termination date
- Oct 22, 2021
- Reason for recall
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
- Recall initiation date
- Oct 6, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 2, 2020