FDA recall D-1543-2016

Pharmacy Plus, Inc. dba Vital Care Compounder · Class II · drug

Product

Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS

Reason for recall

Lack of Assurance of Sterility

Distribution

MS

Key facts

Status
Terminated
Initiation date
2016-07-26
Report date
2016-10-05
Termination date
2016-11-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hattiesburg, MS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1543-2016