The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1201-2016·Announced 2016-07-20

Medaus Recalls Lipo with Lidocaine Vials Due to Sterility Concerns

Medaus, Inc. is recalling Lipo with Lidocaine #3 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, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe; while specific injury reports are not detailed, the lack of sterility assurance in an injectable product represents a significant health risk consistent with the Severe tier for Class II drug recalls.

Plain-English summary

Medaus, Inc. is recalling Lipo with Lidocaine #3 with preservative (benzyl ethyl alcohol 2%) and various vitamins and minerals, including ascorbic acid, B vitamins, D3, methionine, inositol, choline chloride, and lidocaine. The product is available 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 includes 7,000 mL in vials. Specific lots involved are 160107-37 with a beyond-use date of July 5, 2016, and 160303-67 with a beyond-use date of July 31, 2016. The product was distributed nationwide in the United States, as well as in Japan and New Zealand.

Consumers and healthcare providers should stop using the affected vials 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 could cause temporary or medically reversible health consequences.

The recalled product

Product
LIPO W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;D3-30MG; B5-5MG;B6-5MG;CYANO B12-1MG; METHIONINE 12.5MG; INOSITOL-25MG; CHOLINE CL-25 MG; LIDOCAINE 10MG/ML, In a) 5 ML 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 #: 160107-37
  • BUD: 07/5/16
  • Lot #: 160303-67
  • BUD: 07/31/16. b) Lot #: 160107-37
  • 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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