Reported Nov 25, 2015 · Terminated

BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL…

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Kalman Health & Wellness, Inc. dba Essential Wellness Pharma · 4625 N University St · Peoria, IL · 61614-5828

Is this the product you have?

  • BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lot codes and dates
    • Lot #: 071015
    • Exp 09/10/2015
    • 072115
    • Exp 09/21/2015
    • and 080715
    • Exp 10/07/2015
Amount recalled
5 vials

This recall covers 39 products

The agency filed one notice per product. You are reading one of them; the other 38 are below.

26 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 29, 2017 · Data as of Sep 19, 5:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.