Class II
Terminated
Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
- Company
- Sandoz Inc
- Recall Initiated
- August 24, 2016
- Posted
- September 28, 2016
- Recall Number
- D-1514-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 1,584 cartons; b) 62,170 vials
- Firm Location
- Princeton, NJ, United States
Reason for Recall
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: a) 091914, Exp 09/16; b) 080114, Exp 08/16; 090414, 092614, Exp 09/16
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