D-0927-2022 Class II
FDA drug recall D-0927-2022 was initiated by Olympia Compounding Pharmacy Dba Olympia Pharmacy on May 9, 2022 and is designated Class II. Reason for recall: Lack of assurance of sterility. Affected quantity: 1703 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 1, 2022
- Initiation Date
- May 9, 2022
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0927-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026