The Recall Desk
SevereFDA (Drugs)·D-1170-2016·Announced 2016-07-20

Medaus Recalls B-Complex Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of B-Complex Without B12 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, which corresponds to a Severe severity score under the rubric for potential serious, reversible health consequences.

Plain-English summary

Medaus, Inc. is recalling specific lots of B-Complex Without B12 (PF) in NaCl 0.9% vials. The recall is being conducted because the company lacks assurance of the sterility of the affected product.

The recalled product consists of 2 mL and 5 mL vials containing B1, B2, B3, B5, and B6. The affected lots are 151130-66, 160222-51, and 151130-60. The distribution of these products was nationwide in the U.S., as well as in Japan and New Zealand.

Consumers and healthcare providers should stop using the affected vials and contact Medaus, Inc. for further instructions or a return.

The recalled product

Product
B-COMPLEX WITHOUT B12 (PF) IN NACL 0.9%, B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
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 #: 151130-66
  • BUD: 05/28/16
  • Lot #: 160222-51
  • BUD: 08/20/16. b) Lot #: 151130-60
  • BUD: 08/20/16.

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 →