The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1234-2016·Announced 2016-07-20

Medaus Recalls Pyridoxal and Thiamine Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific vials of Pyridoxal/Thiamine/Lidocaine due to a lack of assurance of sterility. The affected products were 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in injectable medication, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Medaus, Inc. is recalling 2 mL vials of Pyridoxal 50 mg/Thiamine 50 mg/Lidocaine 1% NS (PF) due to a lack of assurance of sterility. The recall affects Lot # 160104-67 with a beyond-use date of 07/02/16.

The affected products were distributed nationwide in the United States, as well as in Japan and New Zealand. The FDA has classified this recall as Class II, indicating a situation where 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. Do not use the product if the sterility cannot be verified.

The recalled product

Product
PYRIDOXAL 50 MG/THIAMINE 50 MG/LIDOCAINE 1% NS (PF), 2ML 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 (2)

  • Lot #: 160104-67
  • BUD: 07/02/16

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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