FDA recall D-1029-2013

Product

EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations, Randolph, NJ 07869

Reason for recall

Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.

Distribution

NJ

Key facts

Status

Terminated

Initiation date

2013-08-26

Report date

2013-09-18

Termination date

2016-04-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Randolph, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1029-2013