D-0816-2022 Class II Terminated
FDA drug recall D-0816-2022 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: 2887 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
- 2887 vials
Product Description
FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0006-10.
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: F41414 BUD: 6/14/2022, F41C14 BUD: 6/14/2022, I24E28 BUD: 9/28/2022, I24F28 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-0816-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026