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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Product Detail

Product Description HCG 270 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Recall Number D-127-2014
Classification Class II
Code Info all codes distributed prior to and including 05/23/2013
Product Distributed Qty 4648 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.

Event Detail

Event Id 65479
Product Type Drugs
Status Ongoing
Recalling Firm Main Street Family Pharmacy, LLC
City Newbern
State TN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-28
Initial Firm Notification of Consignee or Public 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