FDA Drug Recalls

Recalls / Class II

Class IID-0201-2017

Product

Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag, Injection Solution for IV Use Only, Rx Only, Cantrell Drug Company 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-056-30

Affected lot / code info
Lot: 9210

Why it was recalled

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

Recalling firm

Firm
Cantrell Drug Company
Notification channel
Press Release
Type
Voluntary: Firm initiated
Address
7321 Cantrell Rd, Little Rock, Arkansas 72207-4144

Distribution

Quantity
2681 bags
Distribution pattern
Nationwide

Timeline

Recall initiated
2016-11-18
FDA classified
2016-12-13
Posted by FDA
2016-12-21
Terminated
2020-04-29
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0201-2017. 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