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Recall Observatory FDA recall evidence

Drug product

Tri-mix T105, 30 mg/1 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

D-0163-2015

August 27, 2014

Class II

Product summary

Firm
Martin Avenue Pharmacy, Inc.
Event
Event 69152
Status
Terminated
Classification
Class II
Quantity
1,150 mL
Official record key
drug-enforcement:D-0163-2015

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: 06102014@44, Exp 9/8/2014; 06262014@8, Exp 9/24/2014; 07182014@30, Exp 10/16/2014; 07302014@16, Exp 10/28/2014; 08062014@29, Exp 11/4/2014; 08132014@37, Exp 11/11/2014

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility

Field note

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