D-0927-2022 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- June 1, 2022
- Initiation Date
- May 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1703 vials
Product Description
Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine 0.02 mg/mL, Packaged as a)2.5 mL Multi-Dose vial, NDC 73198-0001-03; b) 10 mL Multi-Dose vial, NDC 73198-0001-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Reason for Recall
Lack of assurance of sterility.
Distribution Pattern
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Code Information
Lots: K41C09, K41B09 BUD: 11/9/2022, and A24C19-22 BUD: 1/19/2023