FDAFDA · Food and drugs·Recall number D-1167-2017
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)
Published September 27, 2017 · Recall initiated: August 22, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HYDROMORPHONE HYDROCHLORIDE
- Manufacturer
- Pfizer Inc.
- Distributor
- United States Nationwide (including Puerto Rico) and Singapore
- Lot
- Lot: 760853A
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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