Recall archive / FDA drug enforcement

FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only,... — FDA record D-0925-2022

Reported completed

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 May 9, 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: FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, 6700 Olympia Pharmaceuticals, Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0006-10
Reason: Lack of assurance of sterility.
Classification: Class II
Recalling firm: Olympia Compounding Pharmacy dba Olympia Pharmacy
Quantity: 1159 vials
Agency-reported status: Completed
Source record identifier: D-0925-2022

Open the official record

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

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot: B41C22-22 BUD: 2/22/2023

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

Distribution

Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands

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: Jun 1, 2022
Recall initiation date: May 9, 2022
Center classification date: May 25, 2022

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.