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Recall Observatory FDA recall evidence

Drug product

Wydase 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

D-322-2014

May 28, 2013

Class II

Product summary

Firm
Main Street Family Pharmacy, LLC
Event
Event 65479
Status
Terminated
Classification
Class II
Quantity
50 units
Official record key
drug-enforcement:D-322-2014

Official wording

Reason: Lack of Assurance of Sterility

Code information: all codes distributed prior to and including 05/23/2013

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility