Essential Wellness Pharma Recalls Compounded Progesterone Injections for Sterility Concerns
Essential Wellness Pharma is recalling compounded progesterone injections due to poor sterile production practices that compromised 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 sterility assurance failures in injectable drugs are categorized as Severe.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling 50 vials of Progesterone 100 mg/mL IM Injection in Sesame Oil. The affected product is a prescription-only medication distributed nationwide.
The recall was initiated because observations indicated poor sterile production practices, resulting in a lack of assurance of sterility for the finished drugs. The recall covers all compounded sterile preparations within their expiry dates.
The specific lots affected are 062315 (Exp 09/23/2015), 071615 (Exp 10/16/2015), and 080615 (Exp 11/06/2015). Consumers and healthcare providers should stop using these products and contact their pharmacist or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Affected units
- 50
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 (6)
- Lot #: 062315
- Exp 09/23/2015
- 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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