FDA-Drug2023-03-08Class II
Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottle NDC 16729-008-16, UPC 3 16729 00816 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Accord Healthcare, Inc.
Hazard
CGMP Deviations: recalling drug products following an FDA inspection.
Sold states
United States including Puerto Rico and Canada
Affected count
9600 bottles
Manufactured in
1009 Slater Rd Ste 210B, N/A, Durham, NC, United States
Products
Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottle NDC 16729-008-16, UPC 3 16729 00816 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0421-2023Don't want to check this manually?
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