The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1207-2016·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 company cannot ensure the product is sterile.

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, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

Medaus, Inc. is recalling 4,000 mL of Lipo-Injection vials in 5 mL and 10 mL sizes. The recall is due to a lack of assurance of sterility for the affected product.

The affected lots are 151210-40 (expiration date 05/26/16) and 160229-60 (expiration date 07/31/16). The product was distributed nationwide in the United States, as well as in Japan and New Zealand.

Consumers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the source of purchase or the recalling firm.

The recalled product

Product
LIPO-INJECTION W/METHYL B12 500 MCG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
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 #: 151210-40
  • BUD: 05/26/16
  • Lot #: 160229-60
  • BUD: 07/31/16. b) Lot #: 151210-40
  • 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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