FDA Drug Recalls

Recalls / Class II

Class IID-0042-2018

Product

Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services, LLC. 12620 W. Airport Blvd. #130 Sugar Land, TX 77478, NDC# 71019-242-02

Affected lot / code info
All unexpired lots.

Why it was recalled

Subpotent Drug

Recalling firm

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

Distribution

Quantity
534 bags
Distribution pattern
Nationwide.

Timeline

Recall initiated
2017-09-01
FDA classified
2017-10-25
Posted by FDA
2017-11-01
Terminated
2020-01-24
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0042-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls