FDAFDA · Food and drugs·Recall number D-561-2013
Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Published June 12, 2013 · Recall initiated: May 2, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- THE COMPOUNDING SHOP, INC.
- Distributor
- Florida, California, Minnesota, and Maine
- Lot
- All Lots
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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