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Recall Observatory FDA recall evidence

Drug product

Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK

D-0004-2017

September 12, 2016

Class II

Product summary

Firm
The Apothecary Shoppe LLC
Event
Event 75212
Status
Terminated
Classification
Class II
Quantity
247.5 mL total volume
Official record key
drug-enforcement:D-0004-2017

Official wording

Reason: Lack of Assurance of Sterility; medication was sterilized with a recalled filter

Code information: 07252016@22 BUD 09/22/2016; 08102016@28 BUD 10/08/2016

Distribution pattern: Oklahoma

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility