Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healt...
FDA Recall #D-0423-2023 — Class II — February 7, 2023
Product Description
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
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
120 bottles
Distribution
United States including Puerto Rico and Canada
Code Information
Batches: R2201294, Exp. Date 8/31/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated