Medaus Recalls B-Complex 50 Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of B-Complex 50 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, which corresponds to a 'Severe' rating under the rubric for significant injury risks or hospitalization reports, though no specific injuries are detailed in the provided text.
Plain-English summary
Medaus, Inc. is recalling 4,000 mL of B-Complex 50 in NaCl 0.9% with preservative (Benzyl Ethyl 2%) 10 mL vials. The recall is being conducted because the company lacks assurance of the sterility of the product.
The affected product includes Lot # 151220-4 with a best-use date of 06/17/16 and Lot # 160216-31 with a best-use date of 08/14/16. The product was distributed nationwide in the U.S., as well as in 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
- B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 10ML 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 (4)
- Lot #: 151220-4
- BUD: 06/17/16
- Lot #: 160216-31
- BUD: 08/14/16
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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