The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1208-2016·Announced 2016-07-20

Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the FDA determined there is a lack of assurance of sterility.

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 FDA classified this as a Class II recall. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility in an injectable product is categorized as Severe (Score 4), particularly given the potential for serious injury from non-sterile injections.

Plain-English summary

Medaus, Inc. is recalling approximately 7,000 mL of Lipo-Injection vials containing methyl B12, carnitine, and other ingredients. The recall was initiated because the FDA determined there is a lack of assurance of sterility for the affected product.

The affected product is available in 5 mL and 10 mL vials. The specific lots subject to recall are 151228-58 (expiration date 05/26/16) and 160203-6 (expiration date 07/31/16). The product was distributed in the United States, Japan, and New Zealand.

Consumers and healthcare providers should stop using the affected lots and contact Medaus, Inc. for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, CARNITINE 25MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS…
Manufacturer
Medaus, Inc.
Category
Drug — Injectable Medication
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 #: 151228-58
  • BUD: 05/26/16
  • Lot #: 160203-6
  • BUD: 07/31/16. b) Lot #: 151228-58
  • 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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