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Recall Observatory FDA recall evidence

Drug product

Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

D-770-2013

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
5
Official record key
drug-enforcement:D-770-2013

Official wording

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

Code information: B31012 Exp 8/31/13, B5102 Exp 8/10/13, C5228 Exp 9/22/13, B5012 Exp 12/31/13, and C5111 exp 9/11/13

Distribution pattern: Nationwide and PR

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility