Medaus Recalls L-Carnitine Vials Due to Sterility Concerns
Medaus, Inc. is recalling L-Carnitine 50mg/mL vials because the company cannot ensure the product is sterile. The recall covers distribution in the U.S., Japan, and New Zealand.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection associated with non-sterile injectable medications.
Plain-English summary
Medaus, Inc. is recalling L-Carnitine 50mg/mL (PF), 10mL vials due to a lack of assurance of sterility. The affected product is identified by Lot # 160303-62 with a best-use-by date of 08/30/16. The recall involves 2,000 mL in vials.
The product was distributed nationwide in the United States, as well as in Japan and New Zealand. The recall was initiated because the manufacturer could not guarantee that the medication was sterile.
Consumers and healthcare providers should stop using the recalled product and contact Medaus, Inc. for further instructions or a refund.
The recalled product
- Product
- L-CARNITINE 50MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable Medication
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 #: 160303-62
- 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.
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