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Recall Observatory FDA recall evidence

Drug 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

D-1419-2012

April 17, 2012

Class I

Product summary

Firm
Hospira Inc.
Event
Event 61624
Status
Terminated
Classification
Class I
Quantity
212,370 cartidges
Official record key
drug-enforcement:D-1419-2012

Official wording

Reason: Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL

Code information: Lot #10830LL, Exp. 1APR2013

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent