PlainRecalls
FDA Drug Moderate Class II Terminated

FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy

Reported: May 24, 2017 Initiated: April 18, 2017 #D-0719-2017

Product Description

FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy

Reason for Recall

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

Details

Units Affected
12 vials total (3/2mL vials and 9/10mL vias)
Distribution
Distributed nationwide in U.S.A., Australia and Canada.
Location
Federal Way, WA

Frequently Asked Questions

What product was recalled?
FOLINIC ACID MDV INJ, Injection, 10 mg/mL, Rx only, packaged in 2mL and 10 mL glass/Multiple Dose vials, Prepared by Key Compounding Pharmacy. Recalled by Key Pharmacy and Compounding Center. Units affected: 12 vials total (3/2mL vials and 9/10mL vias).
Why was this product recalled?
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 24, 2017. Severity: Moderate. Recall number: D-0719-2017.