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Recall Observatory FDA recall evidence

Drug product

Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmacy, Orlando, FL

D-773-2013

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
6
Official record key
drug-enforcement:D-773-2013

Official wording

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

Code information: 0.75% Lot L5611 Exp 11/30/13 // 1% Lot b3001 Exp 6/19/13, B5014 Exp 8/14/13, and A5431 Exp 6/4/13 // 3% Lot A5808 Exp 12/31/13 // 10% Lot C5328 Exp 9/3/13

Distribution pattern: Nationwide and PR

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility