The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1175-2016·Announced 2016-07-20

Medaus Recalls B-Complex and Lidocaine Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of B-Complex with Methyl B12 and Lidocaine vials because the company cannot guarantee 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 severity score under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

Medaus, Inc. is recalling specific lots of B-Complex with Methyl B12 and Lidocaine vials. The recall was initiated because the company lacks assurance of the product's sterility. The affected product is available in 1 mL, 5 mL, and 10 mL vials.

The recall covers 370 mL of product in vials distributed nationwide in the United States, as well as in Japan and New Zealand. Specific lot numbers and expiration dates are listed in the recall documentation.

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

The recalled product

Product
B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, LIDOCAINE 1%, METHYL B12 1MG/ML, In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable Medication
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 (20)

  • a) Lot #: 151228-62
  • BUD: 06/25/16. b) Lot #: 160111-2
  • BUD: 06/11/16
  • Lot #: 160113-3
  • Lot #: 160113-76
  • Lot #: 160118-1
  • Lot #: 160119-2
  • Lot #: 160119-65
  • Lot #: 160122-9
  • Lot #: 160128-10
  • Lot #: 160202-65
  • Lot #: 160204-44
  • Lot #: 160217-54
  • Lot #: 160223-5
  • Lot #: 160224-66
  • Lot #: 160229-23
  • Lot #: 160315-3
  • BUD: 06/11/16. c) Lot #: 160118-1
  • Lot #: 160127-2
  • Lot #: 160210-37

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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