The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1205-2016·Announced 2016-07-20

Medaus Recalls Lipo-Boost Vials Due to Sterility Assurance Concerns

Medaus, Inc. is recalling Lipo-Boost vials because the company cannot guarantee the product's sterility. The recall covers 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. According to the rubric, an FDA Class II recall involving a risk of serious health consequences (such as lack of sterility in an injectable product) corresponds to a severity score of 4 (Severe).

Plain-English summary

Medaus, Inc. is recalling specific lots of Lipo-Boost W/PRES. (Benzyl Ethol 2%) vials. The product contains a mixture of vitamins, amino acids, and lidocaine. The recall is being conducted because the manufacturer lacks assurance of the product's sterility.

The affected product is available in 3 mL and 5 mL vials. The specific lots involved are 160209-36 (expiration date 07/31/16), 151202-20 (expiration date 05/26/16), and 151214-49 (expiration date 05/26/16). The total quantity involved is 65 mL in vials.

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 recalled product

Product
LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50 MG, METHIONINE 12.5MG, INOSITOL 25MG, CHOLINE CHL-25MG, LIDOCAINE 30MG/ML, In a) 3ML Vials and b) 5ML 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 #: 160209-36
  • BUD: 07/31/16. b) Lot #: 151202-20
  • BUD: 05/26/16
  • Lot #: 151214-49
  • 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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