D-0901-2022 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
- 874 vials
Product Description
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; 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: L24D14, L24C14 BUD: 12/14/2022