PlainRecalls
FDA Drug Moderate Class II Terminated

MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

Reported: June 12, 2013 Initiated: May 2, 2013 #D-566-2013

Product Description

MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

Reason for Recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Details

Units Affected
14 vials of 30mL each
Distribution
Florida, California, Minnesota, and Maine
Location
St Petersburg, FL

Frequently Asked Questions

What product was recalled?
MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL. Recalled by THE COMPOUNDING SHOP, INC.. Units affected: 14 vials of 30mL each.
Why was this product recalled?
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Which agency issued this recall?
This recall was issued by the FDA Drug on June 12, 2013. Severity: Moderate. Recall number: D-566-2013.