The Recall Desk
SevereFDA (Drugs)·D-1194-2016·Announced 2016-07-20

Medaus Recalls L-Carnitine Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of L-Carnitine 100mg/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 mapped to a severity score of 4 (Severe), particularly when involving sterility assurance issues for injectable products.

Plain-English summary

Medaus, Inc. is recalling L-Carnitine 100mg/mL (PF) 10mL vials due to a lack of assurance of sterility. The affected product is identified by the following lot numbers and expiration dates: Lot 151123-18 (BUD 05/21/16), Lot 151124-39 (BUD 05/22/16), and Lot 160203-42 (BUD 08/01/16). The total quantity involved is 1,400 mL in vials.

The recall covers product 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, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected lots and contact Medaus, Inc. for further instructions or a refund. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product
L-CARNITINE 100MG/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 (6)

  • Lot #: 151123-18
  • BUD: 05/21/16
  • Lot #: 151124-39
  • BUD: 05/22/16
  • Lot #: 160203-42
  • 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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Same hazard · sterility

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