FDA Drug Class II — Moderate

BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-202-16 UPC 3 16729 20216 9

Hazard

CGMP Deviations: recalling drug products following an FDA inspection.

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Products

BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382
Brand
Accord Healthcare, Inc.
UPC
Batches: P2105472, Exp. Date 4/30/2024;

Units Affected

3,784 bottles

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