FDA Drug Recalls

Recalls / Class II

Class IID-1544-2016

Product

Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS

Affected lot / code info
Lot #: 365204, Use by 8/1/16 and 384395, Use by 3/12/17

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
Pharmacy Plus, Inc. dba Vital Care Compounder
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
115 S 40th Ave, N/A, Hattiesburg, Mississippi 39402-6600

Distribution

Quantity
139 vials
Distribution pattern
MS

Timeline

Recall initiated
2016-07-26
FDA classified
2016-09-27
Posted by FDA
2016-10-05
Terminated
2016-11-18
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1544-2016. 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