The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1196-2016·Announced 2016-07-20

Medaus Recalls L-Carnitine Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of L-Carnitine 250mg/mL vials because the company cannot guarantee 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility failure) where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

Medaus, Inc. is recalling L-Carnitine 250mg/mL (PF) 10mL vials. The recall is being conducted because the company lacks assurance of the sterility of the affected product.

The recall covers 2,250 mL in vials distributed to Medaus Pharmacy. The affected lots were distributed nationwide in the United States, as well as in Japan and New Zealand. The specific lot numbers and expiration dates are: 151123-72 (05/21/16), 151124-33 (05/22/16), 151217-18 (06/14/16), 151217-22 (06/14/16), 151221-3 (06/18/16), and 160303-64 (08/30/16).

Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
L-CARNITINE 250MG/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 (11)

  • Lot #: 151123-72
  • BUD: 05/21/16
  • Lot #: 151124-33
  • BUD: 05/22/16
  • Lot #: 151217-18
  • BUD: 06/14/16
  • Lot #: 151217-22
  • Lot #: 151221-3
  • BUD: 06/18/16
  • Lot #: 160303-64
  • BUD: 08/30/16

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.

See all →

Same hazard · sterility failure

See all →

Similar recalls