FDA Drug Recalls

Recalls / Class III

Class IIID-1226-2014

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.

Affected lot / code info
Lot: 221303A, 1OCT2014

Why it was recalled

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

Recalling firm

Firm
Hospira Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579

Distribution

Quantity
237,850 ampoules
Distribution pattern
Nationwide

Timeline

Recall initiated
2014-03-25
FDA classified
2014-04-08
Posted by FDA
2014-04-16
Terminated
2015-12-18
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1226-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.