Recalls / Class I
Class ID-020-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
HYDROmorphone HCl Injection, USP, 2 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 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit).
- 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 12720LL, Exp 12/01/13
Why it was recalled
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 216,880 cartridge units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-08-15
- FDA classified
- 2012-10-24
- Posted by FDA
- 2012-10-31
- Terminated
- 2015-05-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-020-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.