Essential Wellness Recalls Testosterone Cypionate Injection Due to Sterility Concerns
Essential Wellness Pharmacy is recalling Testosterone Cypionate 50 mg/mL injections due to poor sterile production practices that compromise sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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 and involves a lack of sterility assurance in compounded sterile preparations, which poses a risk of serious health consequences such as infection.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling Testosterone Cypionate 50 mg/mL Injection, 1 mL vials. The recall is being initiated because of observations associated with poor sterile production practices, which resulted in a lack of sterility assurance for the finished drugs.
The affected product is Lot # 081215, with an expiration date of 11/12/2015. The recall covers all compounded sterile preparations within their expiry date. The distribution pattern is listed as nationwide.
Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Affected units
- 5
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 (2)
- Lot #: 081215
- Exp 11/12/2015
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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