RecallRadar

FDA Drug recall D-1542-2016

Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml…

On 2016-10-05 the FDA classified a Class II recall of Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml… by Pharmacy Plus, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1542-2016
ClassificationClass II
Statusterminated
Initiated2016-07-26
Published2016-10-05
Last updated2026-09-13 11:51 UTC
CompanyPharmacy Plus
DistributionMS

Product

Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS

Reason

Lack of Assurance of Sterility

Identifiers

code_infoLot# 397267, Use by 9/20/16

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1542-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.