RecallRadar

FDA Drug recall D-1190-2016

HYDROXY B12 5MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY

On 2016-07-20 the FDA classified a Class II recall of HYDROXY B12 5MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY by Medaus, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1190-2016
ClassificationClass II
Statusterminated
Initiated2016-05-13
Published2016-07-20
Last updated2026-09-13 11:51 UTC
CompanyMedaus
DistributionUS

Product

HYDROXY B12 5MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY

Reason

Lack of Assurance of Sterility

Identifiers

code_info
Lot #: 160202-12, BUD: 07/11/16; Lot #: 160204-10, BUD: 07/11/16; Lot #: 160210-70, BUD: 07/11/16; Lot #: 160215-11,…Lot #: 160202-12, BUD: 07/11/16; Lot #: 160204-10, BUD: 07/11/16; Lot #: 160210-70, BUD: 07/11/16; Lot #: 160215-11, BUD: 07/11/16; Lot #: 160222-17, BUD: 07/11/16; Lot #: 160223-64, BUD: 07/11/16; Lot #: 160224-67, BUD: 07/11/16; Lot #: 160307-28, BUD: 07/11/16; Lot #: 160308-1, BUD: 07/11/16; Lot #: 160309-3, BUD: 07/11/16

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-1190-2016%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.