The Recall Desk
SevereFDA (Drugs)·D-1172-2016·Announced 2016-07-20

Medaus Recalls B-Complex 50 Vials Due to Sterility Concerns

Medaus, Inc. is recalling B-Complex 50 in NaCl 0.9% vials because the company cannot assure the sterility of the product.

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 the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of infection or serious injury.

Plain-English summary

Medaus, Inc. is recalling B-Complex 50 in NaCl 0.9% (PF) 2 mL vials. The recall is being conducted because the company lacks assurance of the sterility of the product.

The affected product is identified by Lot # 160218-57 with a beyond-use date of 08/16/16. The product was distributed in the United States, Japan, and New Zealand.

Healthcare providers and patients should stop using the affected vials and contact Medaus, Inc. for further instructions or a replacement.

The recalled product

Product
B-COMPLEX 50 IN NACL 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 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 (2)

  • Lot #: 160218-57
  • BUD: 08/16/16

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.

See all 88 products in this recall →

Related recalls

Same manufacturer · Medaus, Inc.

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Same hazard · sterility

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