The Recall Desk
SevereFDA (Drugs)·D-1204-2016·Announced 2016-07-20

Medaus Recalls Lipo B Cyano Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of Lipo B Cyano 1mg/mL vials because the company cannot ensure the product is sterile.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential serious injury or structural defects, and the rule states that FDA Class I or USDA Class I never go below 4, implying Class II with significant risk factors like sterility issues aligns with the Severe category in the absence of explicit Class I designation but high risk.

Plain-English summary

Medaus, Inc. is recalling specific lots of Lipo B Cyano 1mg/mL vials containing methionine, inositol, choline chloride, and cyanocobalamin. The recall is being conducted because the company lacks assurance of the sterility of the product.

The affected product is available in 5 mL and 10 mL vials. The specific lots subject to recall are 151203-50, 160128-34, 160229-51, 151204-10, and 151204-19. The distribution of these products was nationwide in the United States, as well as in Japan and New Zealand.

Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled lots. The FDA has classified this recall as Class II, indicating a reasonable probability that temporary or medically reversible adverse health consequences could occur.

The recalled product

Product
LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, CHOLINE CHL-50MG, CYANO B-12-100MCG, BENZYL ALCOHOL 1%/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 (8)

  • a) Lot #: 151203-50
  • BUD: 05/26/16
  • Lot #: 160128-34
  • BUD: 07/26/16
  • Lot #: 160229-51
  • BUD: 07/31/16. b) Lot #: 151204-10
  • Lot #: 151204-19
  • 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 →

Related recalls

Same manufacturer · Medaus, Inc.

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Same hazard · sterility

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