The Recall Desk
SevereFDA (Drugs)·D-316-2016·Announced 2015-11-25

Essential Wellness Recalls Methylcobalamin Syringes Due to Sterility Concerns

Essential Wellness Pharmacy is recalling Methylcobalamin 20 mg/mL prefilled syringes due to poor sterile production practices that compromised 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 compounded sterile preparations, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes. The recall affects 28 prefilled syringes per package, specifically Lot # 3327-081715 with an expiration date of 09/17/2015. 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 sterility assurance for the finished compounded sterile preparations.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for instructions on return or disposal.

The recalled product

Product
Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Manufacturer
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Category
Drug — Compounded Sterile Preparation
Hazard
Affected units
28

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 (2)

  • Lot #: 3327-081715
  • Exp 09/17/2015

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.

See all 39 products in this recall →

Related recalls

Same manufacturer · Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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Same hazard · sterility failure

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