RecallRadar

FDA Drug recall D-0718-2017

FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compo…

On 2017-05-24 the FDA classified a Class II recall of FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compo… by Key Pharmacy And Compounding Center, citing lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0718-2017
ClassificationClass II
Statusterminated
Initiated2017-04-18
Published2017-05-24
Last updated2026-09-13 11:51 UTC
CompanyKey Pharmacy And Compounding Center
DistributionUS

Product

FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy

Reason

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Identifiers

code_infoLot # t02-09-2017@74, Exp 5/15/2017; t02-17-2017@89, Exp 5/21/2017; t02-20-2017@72, Exp 5/22/2017.

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-0718-2017%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.