FDA Drug Recalls

Recalls / Class II

Class IID-0742-2016

Product

Sufentanil Cit 1000 mcg/ml/Baclofen 300 mcg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

Affected lot / code info
BUD: 5/3/2016

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
Hartley Medical Center Pharmacy, Incorporated
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
113 W Victoria St, N/A, Long Beach, California 90805-2162

Distribution

Quantity
1 syringe
Distribution pattern
Nationwide. No foreign distribution.

Timeline

Recall initiated
2016-02-04
FDA classified
2016-03-04
Posted by FDA
2016-03-16
Terminated
2016-08-09
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0742-2016. 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