Essential Wellness Recalls Methylcobalamin Injections Due to Sterility Concerns
Essential Wellness Pharmacy is recalling Methylcobalamin 5000 mcg/mL 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 and involves a lack of sterility assurance in injectable drugs, which poses a significant risk of serious injury or infection.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in 4 mL and 8 mL vials. The recall is being initiated because of observations associated with poor sterile production practices, which resulted in a lack of sterility assurance for the finished drugs.
The affected products are prescription-only (Rx only) and were distributed nationwide. The recall covers specific lots with the following details: Lot # 072715 (Expiration 09/10/2015) and Lot # 073015 (Expiration 09/13/2015).
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 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 #: 072715
- Exp 09/10/2015
- and 073015
- Exp 09/13/2015
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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