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Recall Observatory FDA recall evidence

Drug product

Tri-mix, 12 mg/1 mg/9 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

D-0146-2015

August 27, 2014

Class II

Product summary

Firm
Martin Avenue Pharmacy, Inc.
Event
Event 69152
Status
Terminated
Classification
Class II
Quantity
50 mL
Official record key
drug-enforcement:D-0146-2015

Official wording

Reason: Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Code information: Lot Number: 07152014@2, Exp 10/13/2014; 08062014@55, Exp 12/22/2014

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility