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Recall Observatory FDA recall evidence

Drug product

Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia Pharmacy, Orlando, FL

D-782-2013

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
10
Official record key
drug-enforcement:D-782-2013

Official wording

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

Code information: 0.125% Lot B3505 Exp 8/1/13 // 1% Lots C5001 Exp 9/30/13, C5406 Exp 9/4/13, and C5306 Exp 9/30/13 // 2.5% Lot C5101 Exp 9/30/13 // 3% Lots B5120 Exp 10/31/13, C5301 Exp 9/30/13, B5428 Exp 6/4/13, and C5212 Exp 9/21/13 // 4% Lot C5301 Exp 9/30/13

Distribution pattern: Nationwide and PR

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility