FDA-Drug2023-03-08Class II
Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-464-63, UPC 3 16729 46463 5; Carton NDC 16729-464-08, UPC 3 16729 46408 6
Accord Healthcare, Inc.
Hazard
CGMP Deviations: recalling drug products following an FDA inspection.
Sold states
United States including Puerto Rico and Canada
Affected count
9,888 vials
Manufactured in
1009 Slater Rd Ste 210B, N/A, Durham, NC, United States
Products
Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-464-63, UPC 3 16729 46463 5; Carton NDC 16729-464-08, UPC 3 16729 46408 6
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0401-2023Don't want to check this manually?
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