D-0805-2022 Class II Terminated
FDA drug recall D-0805-2022 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: 2437 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
- 2437 vials
Product Description
T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg/mL. Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0014-10; b) 5 mL Multi-Dose vial, NDC 73198-0014-05; 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) E41B10 BUD: 5/10/2022; b) E41B08 BUD: 5/10/2022, I41C08 BUD: 9/8/2022, I41D08 BUD: 9/8/2022, E41C10 BUD: 5/10/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0805-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026