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Recall Observatory FDA recall evidence

Drug product

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.

D-0413-2023

February 07, 2023

Class II

Product summary

Firm
Accord Healthcare, Inc.
Event
Event 91657
Status
Terminated
Classification
Class II
Quantity
48,089 cartons
Official record key
drug-enforcement:D-0413-2023

Official wording

Reason: CGMP Deviations: recalling drug products following an FDA inspection.

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

Distribution pattern: United States including Puerto Rico and Canada

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations