Recalls / Class II

Class IID-1514-2016

Product

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.

Affected lot / code info

Lot #: a) 091914, Exp 09/16; b) 080114, Exp 08/16; 090414, 092614, Exp 09/16

Why it was recalled

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

Recalling firm

Firm

Sandoz Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

100 College Rd W, Princeton, New Jersey 08540-6604

Distribution

Quantity

a) 1,584 cartons; b) 62,170 vials

Distribution pattern

Nationwide and Puerto Rico

Timeline

Recall initiated

2016-08-24

FDA classified

2016-09-19

Posted by FDA

2016-09-28

Terminated

2017-07-12

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1514-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.