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)
Reported: September 27, 2017 Initiated: August 22, 2017 #D-1167-2017
Product Description
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 for Recall
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 115,370 vials
- Distribution
- United States Nationwide (including Puerto Rico) and Singapore
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Pfizer Inc.. Units affected: 115,370 vials.
Why was this product recalled? ▼
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 27, 2017. Severity: Moderate. Recall number: D-1167-2017.
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