Progesterone Injection Recalled for Lack of Sterility Assurance
Essential Wellness Pharmacy is recalling Progesterone 100 mg/mL injections due to poor sterile production practices that compromised 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 a sterile injection, which poses a significant risk of serious injury or infection.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials. The recall is initiated because observations associated with poor sterile production practices resulted in a lack of sterility assurance for the finished drugs.
The affected product is identified by Lot # 072915 with an expiration date of 10/29/2015. The distribution pattern is listed as nationwide. The product is a prescription-only compounded sterile preparation.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Affected units
- 1
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 #: 072915
- Exp 10/29/2015
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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