Recalls / Class II
Class IID-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)
- Brand name
- Hydromorphone Hydrochloride
- Generic name
- Hydromorphone Hydrochloride
- Active ingredient
- Hydromorphone Hydrochloride
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDCs
- 0409-1283, 0409-2552, 0409-3356, 0409-2540, 0409-3365, 0409-1312, 0409-1304
- FDA application
- NDA200403
- Affected lot / code info
- Lot: 760853A
Why it was recalled
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 115,370 vials
- Distribution pattern
- United States Nationwide (including Puerto Rico) and Singapore
Timeline
- Recall initiated
- 2017-08-22
- FDA classified
- 2017-09-15
- Posted by FDA
- 2017-09-27
- Terminated
- 2023-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1167-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.