D-0899-2022 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
- 1710 vials
Product Description
RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; 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: K24B09, K24C09 BUD: 11/09/2022