FDA Drug recall D-0733-2018
Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolam…
- FDA Drug
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolam… by Vitalab Pharmacy, citing lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0733-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-24 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vitalab Pharmacy |
| Distribution | US |
Product
Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc
Reason
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Identifiers
| code_info | Lot #:T101 03062018@69, 02052018@56, T104 03122018@62, 02072018@95, T105 03122018@63, 02072018@96, T106 03122018@64, 02072018@97, Exp 06/04/2018-06/10/2018 |
|---|
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-0733-2018%22
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