Status
Terminated
Drug Enforcement D-052-2014
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.
Classification
Class II
Report Date
December 11, 2013
Termination Date
April 22, 2014
Product Information
- Product description
- Betamethasone Na phosphate 4mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Product quantity
- 20 units
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- 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
Location & Firm
- Recalling firm
- Main Street Family Pharmacy, LLC
- Address
-
126 East Main Street, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-052-2014
- Event ID
- 65479
- Recall initiation date
- May 28, 2013
- Center classification date
- December 3, 2013
- Code info
- all codes distributed prior to and including 05/23/2013
- More code info
- —