Reported Nov 25, 2015 · Terminated
HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h)…
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?
12 of 12 products
| # | Product as published |
|---|---|
| 1 | 1 mL |
| 2 | 1.2 mL |
| 3 | 1.6 mL |
| 4 | 2.0 mL |
| 5 | 2.4 mL |
| 6 | 3.6 mL |
| 7 | 4 mL |
| 8 | 4.8 mL vials; and |
| 9 | 0.1 mL |
| 10 | 0. 2 mL |
| 11 | 0.3 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 |
| 12 | University, Peoria, IL 61614. |
- Lot codes and dates
Lot #: 080615Exp 09/06/2015081215Exp 09/12/2015081315Exp 09/13/2015081415Exp 09/14/20151730-081715Exp 09/17/20151730-081815Exp 09/18/2015and 1730-081915Exp 09/19/2015
- Amount recalled
- 21 vials and 80 prefilled syringes
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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