Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthca...
FDA Recall #D-0422-2023 — Class II — February 7, 2023
Product Description
Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-009-15, UPC 3 16729 00915 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
32,688 bottles
Distribution
United States including Puerto Rico and Canada
Code Information
Batches: a )R2200589, R2200689, R2200690, R2201232, Exp. Date 4/30/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated