RecallRadar

FDA Drug recall D-305-2016

Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614

On 2015-11-25 the FDA classified a Class II recall of Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614 by Kalman Health And Wellness, citing lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practi….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-305-2016
ClassificationClass II
Statusterminated
Initiated2015-09-03
Published2015-11-25
Last updated2026-09-13 11:51 UTC
CompanyKalman Health And Wellness
DistributionUS

Product

Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Reason

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Identifiers

code_infoLot #: 071515, Exp 10/15/2015

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-305-2016%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.