Essential Wellness Recalls Methylcobalamin Injections Due to Sterility Concerns
Essential Wellness Pharmacy is recalling Methylcobalamin 1 mg/mL prefilled syringes 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 and involves a lack of sterility assurance in compounded sterile preparations, which poses a significant risk of infection and potential hospitalization, meeting the criteria for a Severe rating.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes. The recall covers 10 prefilled syringes distributed nationwide. The affected lots are 072915 (Exp 09/13/2015), 080415 (Exp 09/19/2015), and 1345-081815 (Exp 10/03/2015).
The recall was initiated due to observations associated with poor sterile production practices. These practices resulted in a lack of sterility assurance for the finished compounded sterile preparations. The FDA has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Affected units
- 10
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 #: 072915
- Exp 09/13/2015
- 080415
- Exp 09/19/2015
- and 1345-081815
- Exp 10/03/2015
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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