FDA Recall D-220-2014
Main Street Family Pharmacy, LLC · Newbern, TN
Class I — life-threatening Terminated 329 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Methylprednisolone 80mg/ml (PF) 10ml, 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.
Recall record
- Recall number
D-220-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- 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
- Recall initiated
- 2013-05-28
- Classified by FDA Center
- 2013-12-03
- FDA published
- 2013-12-11
- Terminated
- 2014-04-22
- Recalling firm
- Main Street Family Pharmacy, LLC
- Firm location
- Newbern, TN