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Recall Observatory FDA recall evidence

Drug product

Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL

D-695-2013

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-695-2013

Official wording

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

Code information: B5008 exp 12/31/13, K5030 Exp. 11/30/13, A5716 Exp. 8/31/13, C5121 Exp 9/12/13, and C5208 Exp 9/7/13

Distribution pattern: Nationwide and PR

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility