FDA Drug Class II — Moderate

BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-203-01, UPC 3 16729 20301 2;

Hazard

CGMP Deviations: recalling drug products following an FDA inspection.

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Products

BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382
Brand
Accord Healthcare, Inc.
UPC
Batches: P2105483, Exp. Date 7/31/2024;

Units Affected

10992 bottles

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