Recalls / Class I
Class ID-1419-2012
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
Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30
- Affected lot / code info
- Lot #10830LL, Exp. 1APR2013
Why it was recalled
Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 212,370 cartidges
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-04-17
- FDA classified
- 2012-07-15
- Posted by FDA
- 2012-07-25
- Terminated
- 2015-05-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1419-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.