Essential Wellness Pharma Recalls Progesterone Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling specific lots of Progesterone 100 mg/mL Ethyl Oleate Injection 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 a sterile injection, which poses a significant risk of infection or serious injury.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling specific lots of Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials. The affected products are prescription-only and were distributed nationwide. The recall involves Lot #072415 (Exp 10/24/2015) and Lot #080715 (Exp 11/07/2015).
The recall was initiated because of observations associated with poor sterile production practices. These practices resulted in a lack of assurance of sterility for the finished compounded sterile preparations. The FDA has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions. Do not use the product if it matches the lot numbers and expiration dates listed above.
The recalled product
- Product
- Progesterone 100 mg/mL Ethyl Oleate Injection, 10 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 #: 072415
- Exp 10/24/2015
- and 080715
- Exp 11/07/2015
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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