The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1171-2016·Announced 2016-07-20

Medaus Recalls B-Complex Vials Due to Sterility Concerns

Medaus, Inc. is recalling B-Complex Without B12 vials because the FDA could not ensure the product was sterile. The recall covers 5 mL and 10 mL vials distributed in the U.S., Japan, and New Zealand.

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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe. While no specific injuries are reported in the text, the 'lack of assurance of sterility' for an injectable product represents a significant risk of serious harm (sepsis/infection), aligning with the Severe criteria for high-risk medical products.

Plain-English summary

Medaus, Inc. is recalling specific lots of B-Complex Without B12 W/PRES (Benzyl Ethoh 2%) in 5 mL and 10 mL vials. The recall was initiated due to a lack of assurance of sterility. The affected product contains B1, B2, B3, B5, and B6.

The recall includes 955 mL in vials distributed to the U.S. nationwide, Japan, and New Zealand. Specific lot numbers and expiration dates are listed in the official recall notice. The product was manufactured by Medaus, Inc.

Consumers and healthcare providers should stop using the affected lots and contact Medaus, Inc. for instructions on return or disposal. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 5ML Vials and b) 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 (19)

  • a) Lot #: 151222-11
  • BUD: 05/28/16
  • Lot #: 151224-5
  • Lot #: 160111-1
  • Lot #: 160119-3
  • Lot #: 160119-64
  • Lot #: 160217-10
  • Lot #: 160307-22
  • BUD: 05/28/16. b) Lot #: 151223-30
  • Lot #: 151224-2
  • Lot #: 160112-2
  • Lot #: 160118-2
  • Lot #: 160125-1
  • Lot #: 160208-4
  • Lot #: 160210-64
  • Lot #: 160215-6
  • Lot #: 160222-14
  • Lot #: 160307-23
  • BUD: 06/11/16.

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 →

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