PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 5, 2016 Initiated: July 26, 2016 #D-1543-2016

Product Description

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

Details

Units Affected
6 vials
Distribution
MS
Location
Hattiesburg, MS

Frequently Asked Questions

What product was recalled?
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. Recalled by Pharmacy Plus, Inc. dba Vital Care Compounder. Units affected: 6 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on October 5, 2016. Severity: Moderate. Recall number: D-1543-2016.