FDA-Drug2023-03-08Class II

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.

Accord Healthcare, Inc.
Hazard

CGMP Deviations: recalling drug products following an FDA inspection.

Sold states
United States including Puerto Rico and Canada
Affected count
48,089 cartons
Manufactured in
1009 Slater Rd Ste 210B, N/A, Durham, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0413-2023

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