FDA-Drug2023-03-08Class II
Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-010-17, UPC 3 16729 01017 7
Accord Healthcare, Inc.
Hazard
CGMP Deviations: recalling drug products following an FDA inspection.
Sold states
United States including Puerto Rico and Canada
Affected count
120 bottles
Manufactured in
1009 Slater Rd Ste 210B, N/A, Durham, NC, United States
Products
Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-010-17, UPC 3 16729 01017 7
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0423-2023Don't want to check this manually?
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