FDAFDA · Food and drugs·Recall number D-0805-2022
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.
Published May 4, 2022 · Recall initiated: April 4, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lots: a) E41B10 BUD: 5/10/2022; b) E41B08 BUD: 5/10/2022, I41C08 BUD: 9/8/2022, I41D08 BUD: 9/8/2022, E41C10 BUD: 5/10/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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