FDA-Drug2020-11-11Class II
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
PD-Rx Pharmaceuticals, Inc.
Hazard
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Sold states
AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI
Affected count
125 bottles
Manufactured in
727 N Ann Arbor Ave, N/A, Oklahoma City, OK, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0060-2021Don't want to check this manually?
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