Medaus Recalls M.I.C 25/50/50 Vials Due to Sterility Concerns
Medaus, Inc. is recalling M.I.C 25/50/50 vials because the product lacks assurance of sterility. The recall affects 2,000 mL in vials 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 in this case a critical sterility failure for an injectable product, are classified as Severe (Score 4).
Plain-English summary
Medaus, Inc. is recalling M.I.C 25/50/50 W/METHYL B12 1MG/PYRIDOXAL 50MG/ML (PF), 1ML Vials. The recall is being conducted because the product lacks assurance of sterility. The affected product consists of 2,000 mL in vials.
The recall covers Lot # 151223-63 with a best-use date of 05/26/16. The product was distributed in the U.S. Nationwide, Japan, and New Zealand.
Consumers and healthcare providers should stop using the affected product and contact Medaus, Inc. for further instructions or a refund.
The recalled product
- Product
- M.I.C 25/50/50 W/METHYL B12 1MG/PYRIDOXAL 50MG/ML (PF), 1ML 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 (2)
- Lot #: 151223-63
- BUD: 05/26/16
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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