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Recall Observatory FDA recall evidence

Drug product

Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, Rx only, NDC 0409-1203-01, Hospira, Inc., Lake Forest, IL.

D-1226-2014

March 25, 2014

Class III

Product summary

Firm
Hospira Inc.
Event
Event 67750
Status
Terminated
Classification
Class III
Quantity
237,850 ampoules
Official record key
drug-enforcement:D-1226-2014

Official wording

Reason: Labeling; Missing label; ampoules are missing the immediate container label

Code information: Lot: 221303A, 1OCT2014

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling; Missing label; ampoules are missing