The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1202-2016·Announced 2016-07-20

Medaus Recalls Lipo #4 Vials Due to Sterility Concerns

Medaus, Inc. is recalling Lipo #4 vials because the FDA cannot assure the product is sterile. The recall affects 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 FDA classified this as a Class II recall. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance for an injectable product represents a significant health risk that aligns with the Severe classification for Class II drug recalls.

Plain-English summary

Medaus, Inc. is recalling Lipo #4 W/Methyl B12 500 mcg/mL vials because the U.S. Food and Drug Administration (FDA) cannot assure the sterility of the product. The recall involves 1,000 mL in vials with Lot # 160203-2 and a best-use-by date of 07/31/16.

The product was distributed nationwide in the United States, as well as in Japan and New Zealand. 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.

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 #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;B3-30MG; B5-5MG;B6-5MG;METHYL B12 500 MCG; LIDOCAINE 10 MG; INOSITOL-25MG; CHOLINE CHL-25 MG/ML; 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 (2)

  • Lot #: 160203-2
  • 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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