Product: 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
Reason for recall: CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated: 20230207
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated