Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x...
FDA Recall #D-0413-2023 — Class II — February 7, 2023
Product Description
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC 16729-493-45, UPC 3 16729 49345 1.
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
48,089 cartons
Distribution
United States including Puerto Rico and Canada
Code Information
Batches: R2101372, R2101397, R2101404, Exp. Date 4/30/2023; R2200264, R2200270, Exp. Date 8/31/2023; R2200382, Exp. Date 9/30/2023; R2200849, Exp. Date 12/31/2023; R2201017, R2201138, Exp. Date 1/31/2024; R2201249, Exp. Date 2/29/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated