Drug recall D-1167-2017
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 for recall
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Lots and codes
Lot: 760853A
Recall details
- Recalling firm
- Pfizer Inc., New York, NY
- Quantity
- 115,370 vials
- Distribution
- United States Nationwide (including Puerto Rico) and Singapore
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 22, 2017
- Terminated
- February 19, 2023
Related products
- Hydromorphone Hydrochloride – drug information
- NDC 0409-1304 Hydromorphone Hydrochloride · Hydromorphone Hydrochloride 4 mg/mL · Hospira, Inc.
- NDC 0409-1312 Hydromorphone Hydrochloride · Hydromorphone Hydrochloride 2 mg/mL · Hospira, Inc.
- NDC 0409-3365 Hydromorphone Hydrochloride · Hydromorphone Hydrochloride 2 mg/mL · Hospira, Inc.
- NDC 0409-1283 Hydromorphone Hydrochloride · Hydromorphone Hydrochloride 1 mg/mL · Hospira, Inc.