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Recall Observatory FDA recall evidence

Drug product

Phentolamine mesylate 5 mg/35 mg/mannitol trituration packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

D-0118-2015

August 27, 2014

Class II

Product summary

Firm
Martin Avenue Pharmacy, Inc.
Event
Event 69152
Status
Terminated
Classification
Class II
Quantity
135.9261 gm
Official record key
drug-enforcement:D-0118-2015

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: 04032014@14, Exp 9/30/2014; 07152014@36, Exp 1/11/2015; 07242014@21, Exp 1/20/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility