T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-000... — FDA record D-0799-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 4, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835 .
Reason
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Classification
Class II
Recalling firm
Olympia Compounding Pharmacy dba Olympia Pharmacy
Quantity
6916 vials
Agency-reported status
Terminated
Source record identifier
D-0799-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLots: a) D41412 BUD: 4/22/2022, E41F10 BUD: 5/10/2022, E41G10 BUD: 5/10/2022, F24D21 BUD: 6/21/2022 ; b) D41512 BUD: 4/12/2022; c) F42B21 BUD: 6/21/2022, H42B03 BUD: 8/3/2022, H42C03 BUD: 8/3/2022

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Distributed Nationwide in the USA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
May 4, 2022
Recall initiation date
Apr 4, 2022
Center classification date
Apr 27, 2022
Termination date
Jun 17, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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