FDA Drug recall D-0799-2022
T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10
- FDA Drug
- Class II
- terminated
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10 by Olympia Compounding Pharmacy, citing CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0799-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-04 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Olympia Compounding Pharmacy |
| Distribution | US |
Product
T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835 .
Reason
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Identifiers
| code_info | Lots: a) D41412 BUD: 4/22/2022, E41F10 BUD: 5/10/2022, E41G10 BUD: 5/10/2022, F24D21 BUD: 6/21/2022 ; b) D41512 BUD: 4/…Lots: a) D41412 BUD: 4/22/2022, E41F10 BUD: 5/10/2022, E41G10 BUD: 5/10/2022, F24D21 BUD: 6/21/2022 ; b) D41512 BUD: 4/12/2022; c) F42B21 BUD: 6/21/2022, H42B03 BUD: 8/3/2022, H42C03 BUD: 8/3/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0799-2022%22
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