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.
Reported: September 28, 2016 Initiated: August 24, 2016 #D-1514-2016
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Details
- Recalling Firm
- Sandoz Inc
- Units Affected
- a) 1,584 cartons; b) 62,170 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sandoz Inc. Units affected: a) 1,584 cartons; b) 62,170 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 28, 2016. Severity: Moderate. Recall number: D-1514-2016.
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