Essential Wellness Pharma Recalls Dexamethasone Ointment Due to Sterility Concerns
Essential Wellness Pharma is recalling Dexamethasone 0.4% Opth Ointment because poor production practices may have compromised sterility.
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 significant risk of infection.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes. The recall covers two specific lots: Lot 062515 (Exp 09/25/2015) and Lot 070615 (Exp 10/06/2015). The product was distributed nationwide.
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 drugs. The agency has classified this as a Class II recall.
Consumers should stop using the recalled ointment and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Category
- Drug — Ophthalmic Ointment
- 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 #: 062515
- Exp 09/25/2015
- and 070615
- Exp 10/06/2015
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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