Bi-mix (papaverine recalls

The FDA has published 2 recalls involving Bi-mix (papaverine since 2015. The latest was reported on 7 Nov 2018. Most were for sterility. Pharm D Solutions has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2015

Last 12 months0reported

Class I00% of total

Ongoing0latest 7 Nov 2018

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why bi-mix (papaverine is recalled

Sterility2100%

Companies

Pharm D Solutions150%
US Compounding150%

By year

2018150%
2015150%

All bi-mix (papaverine recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
7 Nov 2018Drug	CLASS II	Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable recalled	Pharm D Solutions	Sterility	Nationwide
25 Nov 2015Drug	CLASS II	Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL) Multi-Dose Vial recalled	US Compounding	Sterility	Nationwide

Should you stop taking Bi-mix (papaverine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.