Essential Wellness Pharma Recalls Testosterone Cypionate Injections Due to Sterility Concerns
Essential Wellness Pharma is recalling 261 vials of Testosterone Cypionate 200 mcg/mL injection 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant risks such as lack of sterility assurance in injectable drugs are categorized as Severe (Score 4), particularly when the defect involves structural or process failures that could lead to serious injury.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling 261 vials of Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection. The product is packaged in 5 mL and 100 mL vials and is available by prescription only. The recall covers vials distributed nationwide with lot numbers 060815, 061615, 070615, 071615, and 080615, with expiration dates ranging from September 2015 to November 2015.
The recall was initiated due to observations associated with poor sterile production practices. These practices resulted in a lack of assurance of sterility for the finished compounded sterile preparations. The source text does not report any specific illnesses or injuries associated with the use of these products.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Affected units
- 261
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 (10)
- Lot #: 060815
- Exp 09/08/2015
- 061615
- Exp 09/16/2015
- 070615
- Exp 10/06/2015
- 071615
- Exp 10/16/2015
- and 080615
- Exp 11/06/2015
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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