D-0813-2022 Class II Terminated
FDA drug recall D-0813-2022 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: 1849 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
- 1849 vials
Product Description
RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0015-10; b) 2.5 mL Multi-Dose vial, NDC 73198-0015-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
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: a) E47B18 BUD: 5/18/2022; b) E47C18 BUD: 5/18/2022, H24G31 BUD: 8/31/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0813-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026