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Recall Observatory FDA recall evidence

Drug product

Stanozolol (50 mg/ml and 100 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL

D-783-2013

May 29, 2013

Class II

Product summary

Firm
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Event
Event 65360
Status
Ongoing
Classification
Class II
Quantity
3
Official record key
drug-enforcement:D-783-2013

Official wording

Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Code information: 50mg/ml = Lots B5727 Exp 8/27/13, and C5708 Exp 9/8/13 // 100,g/ml =Lot C5706 Exp 9/6/13

Distribution pattern: Nationwide and PR

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility