The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1236-2016·Announced 2016-07-20

Medaus Recalls Pyridoxine HCL Vials Due to Sterility Concerns

Medaus, Inc. is recalling Pyridoxine HCL 100mg/mL vials because the company cannot ensure the product is sterile.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a remote likelihood of adverse health consequences. The hazard is a lack of assurance of sterility, which is a precautionary quality control issue rather than a confirmed contamination event.

Plain-English summary

Medaus, Inc. is recalling Pyridoxine HCL 100mg/mL with preservative (Benzyl Ethyl Alcohol 0.02%) in 5mL vials. The recall is being conducted because the company lacks assurance of the sterility of the product.

The affected product includes 4,000 mL in vials. The specific lots involved are Lot #151220-6 with a beyond-use date of 06/17/16, and Lot #160225-7 with a beyond-use date of 08/23/16. The product was distributed nationwide in the United States, as well as in Japan and New Zealand.

Consumers and healthcare providers should stop using the affected product and contact Medaus, Inc. for further instructions or a return.

The recalled product

Product
PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML 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 (4)

  • Lot #: 151220-6
  • BUD: 06/17/16
  • Lot #: 160225-7
  • BUD: 08/23/16

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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