Essential Wellness Pharma Recalls Testosterone Cypionate Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling Testosterone Cypionate 200 mcg/mL injections because poor sterile production practices resulted in a lack of sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as lack of sterility assurance in injectable drugs.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials. The recall covers two specific lots: Lot #070115 (Exp 10/01/2015) and Lot #071015 (Exp 10/10/2015). The product was distributed nationwide.
The recall was initiated due to observations associated with poor sterile production practices. These practices resulted in a lack of sterility assurance for the finished compounded sterile preparations. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected vials immediately. The source text does not specify a particular action for disposal or return, but users should consult their healthcare provider regarding alternative treatments or next steps.
The recalled product
- Product
- Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 070115
- Exp 10/01/2015
- and 071015
- Exp 10/10/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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