FDA Drug Recalls

Recalls / Class III

Class IIID-0130-2018

Product

morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28

Affected lot / code info
Lot: 172360026C; Exp. 11/23/2017

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp. Date

Recalling firm

Firm
Pharmedium Services, LLC
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506

Distribution

Quantity
Unknown
Distribution pattern
Nationwide.

Timeline

Recall initiated
2017-09-26
FDA classified
2017-12-22
Posted by FDA
2018-01-03
Terminated
2020-05-19
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0130-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.