The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1210-2016·Announced 2016-07-20

Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

Medaus, Inc. is recalling Lipo-Injection vials because the company cannot ensure the product is 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, an FDA Class II recall involving a structural or sterility defect in an injectable drug is rated as Severe (4) due to the risk of serious injury or infection, even without reported fatalities.

Plain-English summary

Medaus, Inc. is recalling specific lots of Lipo-Injection W/Lidocaine W/Pres. (Benzyl Ethoh 2%) in 5 mL and 10 mL vials. The recall is being conducted because the company lacks assurance of the sterility of the product. The affected product contains various vitamins, amino acids, and lidocaine.

The recall includes 14,000 mL in vials. The specific lots affected are 160104-40 (Best Use Date: 05/26/16) and 160209-28 (Best Use Date: 07/31/16). These products were distributed nationwide in the United States, as well as in Japan and New Zealand.

Consumers and healthcare providers should stop using the affected product and contact Medaus, Inc. for further instructions or a refund. The FDA classifies this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE-10MG/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 (5)

  • a) Lot #: 160104-40
  • BUD: 05/26/16
  • Lot #: 160209-28
  • BUD: 07/31/16. b) Lot #: 160104-40
  • BUD: 07/31/16.

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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