RecallRadar

FDA Drug recall D-784-2013

Tacrolimus (0.02% and 0.03%) drops, compounded by Olympia Pharmacy, Orlando, FL

On 2013-07-17 the FDA classified a Class II recall of Tacrolimus (0.02% and 0.03%) drops, compounded by Olympia Pharmacy, Orlando, FL by Lowlite Investments, citing lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-784-2013
ClassificationClass II
Statusongoing
Initiated2013-05-29
Published2013-07-17
Last updated2026-09-13 11:51 UTC
CompanyLowlite Investments
DistributionUS

Product

Tacrolimus (0.02% and 0.03%) drops, compounded by Olympia Pharmacy, Orlando, FL

Reason

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Identifiers

code_infoC51012 Exp 9/12/13 and C51201 Exp 9/6/13

Status history

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

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-784-2013%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.