The Recall Desk
SevereFDA (Drugs)·D-1203-2016·Announced 2016-07-20

Medaus Recalls Lipo-Injection Vials Due to Sterility Assurance Concerns

Medaus, Inc. is recalling Lipo-Injection vials containing lidocaine and vitamins due to a lack of assurance of sterility. The affected products were distributed in the U.S., Japan, and New Zealand.

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. According to the rubric, FDA Class II recalls with potential for hospitalization or significant injury are rated as Severe (4). Lack of sterility assurance in an injectable product poses a significant risk of infection.

Plain-English summary

Medaus, Inc. is recalling Lipo-Injection vials containing lidocaine, ascorbic acid, and various B vitamins. The recall was initiated because of a lack of assurance of sterility in the product. The specific product affected is the 2 mL vial formulation containing 10 mg/mL lidocaine and other listed ingredients.

The recalled product is identified by Lot # 151130-85 with a beyond-use date of 05/26/16. The distribution pattern for this recall includes the United States, Japan, and New Zealand. The total quantity involved is 1000 mL in vials.

Consumers and healthcare providers should stop using the affected product and contact Medaus, Inc. for further instructions or a refund. This recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
LIPO-INJECTION W/LIDOCAINE (PF), ASCORBIC ACID 50MG; B1-50MG; B2-5-PO4-5MG; B3-50MG B5-5MG, B6-5MG, CYANO B-12-100MCG, METHIONINE 12.5 MG, INOSITOL 25 MG, CHOLINE CL-25 MG, LIDCAINE 10 MG/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 #: 151130-85
  • BUD: 05/26/16

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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