RecallRadar

FDA Drug recall D-0418-2015

Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured…

On 2015-09-23 the FDA classified a Class II recall of Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured… by Hospira, citing defective Container: There were customer complaints of cracked and leaking glass vials.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0418-2015
ClassificationClass II
Statusterminated
Initiated2015-08-20
Published2015-09-23
Last updated2026-09-13 11:51 UTC
CompanyHospira
DistributionUS

Product

Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05

Reason

Defective Container: There were customer complaints of cracked and leaking glass vials.

Identifiers

code_infoLot #s: 43406DD, Exp 7/1/2016; 44255DD, Exp 8/1/2016

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-0418-2015%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.