The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1222-2016·Announced 2016-07-20

Medaus Recalls B-Complex Premix Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of M.I.C B-Complex Premix 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 FDA classified this as a Class II recall. According to the rubric, an FDA Class II recall involving a significant risk (sterility failure in an injectable product) corresponds to a 'Severe' rating.

Plain-English summary

Medaus, Inc. is recalling 10 mL vials of M.I.C B-Complex Premix with Hydroxy B12. The recall involves Lot #160229-24 and Lot #160315-5, both with a best-use date of July 25, 2016. The product was distributed nationwide in the United States, as well as in Japan and New Zealand.

The recall was initiated due to a lack of assurance of sterility. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.

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

The recalled product

Product
M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML 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 (3)

  • Lot #: 160229-24
  • BUD: 07/25/16
  • Lot #: 160315-5

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 →

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