FDA Drug Class II — Moderate

Pravastatin Sodium Tablets USP, 80 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 16729-011-15, UPC 3 16729 01115 0

Hazard

CGMP Deviations: recalling drug products following an FDA inspection.

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Products

Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213
Brand
Accord Healthcare, Inc.
UPC
Batches: R2201233, Exp. Date 4/30/2024

Units Affected

1970 bottles

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