Reported Nov 25, 2015 · Terminated
Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N.…
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?
- Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Lot codes and dates
Lot #: 072915Exp 09/13/2015080415Exp 09/19/2015and 1345-081815Exp 10/03/2015
- Amount recalled
- 10 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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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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