RecallRadar

FDA Drug recall D-0991-2016

Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

On 2016-06-15 the FDA classified a Class II recall of Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 by Well Care Compounding Pharmacy, citing lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0991-2016
ClassificationClass II
Statusterminated
Initiated2016-05-17
Published2016-06-15
Last updated2026-09-13 11:51 UTC
CompanyWell Care Compounding Pharmacy
DistributionNV

Product

Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Reason

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Identifiers

code_infoLot #: 01222016:81@52, Exp. 03/25/2016; Lot #:03042016: 23@29, Exp.05/22/2016; Lot #:03212016:35@53, Exp. 05/22/2016

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-0991-2016%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.