Reported Nov 25, 2015 · Terminated
LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only, Essential Wellness PHARMACY,…
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?
LIPO B Injectionpackaged in a) 2 mLb) 12 mLc) 15 mLor d) 30 mL vialsRx onlyEssential Wellness PHARMACY4625 N. UniversityPeoriaIL 61614
- Lot codes and dates
Lot #: 061215Exp 09/12/2015061915Exp 09/19/2015070115Exp 10/01/2015072315Exp 10/23/2015and 073115Exp 10/31/2015
- Amount recalled
- 76 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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