Medaus Recalls Methyl B12 Vials Due to Sterility Concerns
Medaus, Inc. is recalling Methyl B12 10mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.
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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While no injuries are reported, the lack of sterility assurance in an injectable drug presents a significant risk profile consistent with a Severe rating.
Plain-English summary
Medaus, Inc. is recalling Methyl B12 10mg/mL (PF) in NaCl 0.9%, 1mL vials. The recall is being conducted because of a lack of assurance of sterility. The affected product is identified by Lot # 160118-31 with a Beyond Use Date of 07/16/16.
The recalled product was distributed in the U.S. Nationwide, Japan, and New Zealand. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the product.
Consumers and healthcare providers should stop using the affected product and contact Medaus, Inc. for further instructions or a replacement.
The recalled product
- Product
- METHYL B12 10MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable Medication
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 #: 160118-31
- BUD: 07/16/16
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 88 recalled by Medaus, Inc. 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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