Agency classClass IIOur severity:Severe FDA (Drugs)·D-1173-2016·Announced 2016-07-20

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard: sterility
infection

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.

See all 88 products in this recall →

Same manufacturer · Medaus, Inc.

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