The Recall Desk
SevereFDA (Drugs)·D-1055-2013·Announced 2013-09-25

Medaus Recalls NA Ascorbate Injection Due to Sterility Concerns

Medaus, Inc. is recalling NA Ascorbate 500 mg/mL injection due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

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, and the hazard involves microbial contamination in a sterile injectable product, which poses a significant risk of serious injury or hospitalization.

Plain-English summary

Medaus, Inc. is recalling 8,750 mL of NA Ascorbate 500 mg/mL, non corn PF, 100ML vials. The specific lot number is 130613-8, with an expiration date of 12/10/2013. The product was distributed nationwide.

The recall was initiated because laboratory results from a contract lab indicated microbial contamination. The FDA expressed concern that the test results obtained from the recalling firm's contract testing lab may not be reliable, meaning the sterility of the products cannot be assured.

Consumers and healthcare providers should stop using the affected product and contact Medaus Pharmacy at 1-800-526-9183 for further instructions.

The recalled product

Product
NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183
Manufacturer
Medaus, Inc.

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 # 130613-8
  • Exp 12/10/2013

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 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 8 products in this recall →