D-0803-2022 Class II Terminated
FDA drug recall D-0803-2022 was initiated by Olympia Compounding Pharmacy Dba Olympia Pharmacy on Apr 4, 2022 and is designated Class II. Reason for recall: CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated The recall status is terminated (terminated Jun 17, 2024). Affected quantity: 3509 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 4, 2022
- Initiation Date
- Apr 4, 2022
- Termination Date
- Jun 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3509 vials
Product Description
NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10
Reason for Recall
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lots: I24C28 BUD: 9/28/2022, D41I19 BUD: 4/19/2022, F41321 BUD: 6/21/2022, I24128 BUD: 9/28/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0803-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026