Medaus Recalls Hydroxy B12 Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling Hydroxy B12 5mg/mL vials because the company cannot ensure the product is sterile.
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 for an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Medaus, Inc. is recalling Hydroxy B12 5mg/mL in NaCl 0.9% (PF) in 1 mL and 2 mL vials. The recall was initiated because the company lacks assurance of the sterility of the affected product.
The affected lots are 160119-8 (Best Use Date: 07/17/16) and 160204-30 (Best Use Date: 08/02/16). The total quantity involved is 800 mL in vials. The product was distributed nationwide in the United States, as well as in Japan and New Zealand.
Consumers and healthcare providers should stop using the recalled product and contact Medaus, Inc. for further instructions or a replacement.
The recalled product
- Product
- HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable
- Hazard
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 (5)
- a) Lot #: 160119-8
- BUD: 07/17/16
- Lot #: 160204-30
- BUD: 08/02/16. b) Lot #: 160119-8
- BUD: 08/02/16.
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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