FDA Drug recall D-0209-2015
PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97…
- FDA Drug
- Class II
- terminated
- Published 2014-11-12
On 2014-11-12 the FDA classified a Class II recall of PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97… by Oregon Compounding Centers, citing lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0209-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-06 |
| Published | 2014-11-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Oregon Compounding Centers |
| Distribution | OR, WA |
Product
PAPAV HCL/PHENTOL/PROSTAGL, 12mg/1mg/10mcg, injectable, 1.25 mL glass vial or 1.7 ml glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Reason
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Identifiers
| code_info | Lot #: 20140827@30, discard date: 10/11/2014; Lot #: 20140910@28/1.7, discard date: 10/25/2014; Lot #: 20140917@2/1.25, discard date: 11/1/2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0209-2015%22
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