FDAApril 4, 2022drug

T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg/mL. Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0014-10; b) 5 mL Multi-Dose vial, NDC 73198-0014-05; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

What to do

FDA enforcement status: Terminated

Brands named

olympia compounding pharmacy dba olympia pharmacyolympiaolympia compounding

UPCs

7319800141073198001405

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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