FDA Drug Recalls

Recalls / Class II

Class IID-1533-2016

Product

MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402

Affected lot / code info
Lot#: 399080, Use by 8-14-16; 399740, Use by 8-25-16; 398952, Use by 8-13-16; 398865, Use by 8-11-16; 399057, Use by 8-13-16; 398864, Use by 8-11-16

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
6 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-1533-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.