Reported Nov 25, 2015 · Terminated
HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and…
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?
HCG 1000 Units/mL SUB-Q Injectionpackaged in a)1.5 mLb) 2 mLc) 2.4 mLd) 4 mLe) 6 mLf) 7.5 mLg) 8 mLand h) 9 mL vialsRx onlyEssential Wellness PHARMACY4625 N. UniversityPeoriaIL 61614
- Lot codes and dates
Lot #: 080415Exp 09/04/2015080515Exp 09/05/2015080615Exp 09/06/2015080715Exp 09/07/2015081015Exp 09/10/2015081115Exp 09/11/2015081215Exp 09/12/2015081315Exp 09/13/2015081415Exp 09/14/20151702-081715Exp 09/17/20151702-081815Exp 09/18/2015and 1702-081915Exp 09/19/2015
- Amount recalled
- 49 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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