Recall: D-1167-2017

Class II - Potentially Harmful

Class IIClassification

2017-08-22Initiated

TerminatedStatus

Pfizer Inc.Firm

Product

HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)

Reason

Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

Distribution

United States Nationwide (including Puerto Rico) and Singapore

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.