D-096-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 11, 2013
- Initiation Date
- May 28, 2013
- Termination Date
- April 22, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
G-A-C Amino Cocktail 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Reason for Recall
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Distribution Pattern
nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV
Code Information
all codes distributed prior to and including 05/23/2013