Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15,...
FDA Recall #D-0421-2023 — Class II — February 7, 2023
Product Description
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
Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Recalling Firm
Accord Healthcare, Inc. — Durham, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
9600 bottles
Distribution
United States including Puerto Rico and Canada
Code Information
Batches: a) R2201093, Exp. Date 4/30/2024; b) R2201222, R2201231, Exp. Date 4/30/2024;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated