FDA Recall D-1444-2012
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 1112 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit).
Reason for recall
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
Recall record
- Recall number
D-1444-2012- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide.
- Recall initiated
- 2012-05-12
- Classified by FDA Center
- 2012-08-07
- FDA published
- 2012-08-15
- Terminated
- 2015-05-29
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL
Drug identification
- Brand name(s)
- HYDROMORPHONE HYDROCHLORIDE
- Generic name(s)
- HYDROMORPHONE HYDROCHLORIDE
- Manufacturer(s)
- Hospira, Inc.
- NDC(s)
0409-1283, 0409-2552, 0409-3356, 0409-2540, 0409-3365, 0409-1312, 0409-1304- Route(s)
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS