Accord Healthcare, Inc.: Drug Recall

Recall #D-0413-2023 · 02/07/2023

Class II: Risk

Recall Details

Recall Number
D-0413-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Accord Healthcare, Inc.
Status
Terminated
Date Initiated
02/07/2023
Location
Durham, NC, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
48,089 cartons

Reason for Recall

CGMP Deviations: recalling drug products following an FDA inspection.

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.

Distribution Pattern

United States including Puerto Rico and Canada

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.