The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1197-2016·Announced 2016-07-20

Medaus Recalls L-Carnitine Vials Due to Sterility Assurance Concerns

Medaus, Inc. is recalling L-Carnitine 500mg/mL vials because the company cannot assure the product's sterility. The recall covers products 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 recall as Class II. According to the severity rubric, an FDA Class II recall involving a drug product with a sterility defect (which implies a risk of infection) falls under the 'Severe' category, as it is not a Class I recall but involves a significant potential for adverse health consequences.

Plain-English summary

Medaus, Inc. is recalling L-Carnitine 500mg/mL (PF), 10mL vials due to a lack of assurance of sterility. The affected product is identified by Lot # 160203-41 with a beyond-use date of 08/01/16.

The recall covers products distributed in the United States, 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
L-CARNITINE 500MG/ML (PF), 10ML 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 #: 160203-41
  • BUD: 08/01/16

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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