RecallRadar

FDA Drug recall D-0268-2020

S-HYDROXOCOBALAMIN 1000MCG/ML MDV INJ

On 2019-11-13 the FDA classified a Class II recall of S-HYDROXOCOBALAMIN 1000MCG/ML MDV INJ by First Royal Care, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0268-2020
ClassificationClass II
Statusterminated
Initiated2019-08-12
Published2019-11-13
Last updated2026-09-13 11:52 UTC
CompanyFirst Royal Care
DistributionUS

Product

S-HYDROXOCOBALAMIN 1000MCG/ML MDV INJ; packaged in a) 10ML b) 30ML glass vial, Red Mountain Compounding Rx

Reason

Lack of Assurance of Sterility

Identifiers

code_infoLot #:a) S07162019DT@04, Exp 10/16/19; b) S07162019DT@04 Exp 10/16/19

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0268-2020%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.