Medaus Recalls Sodium Ascorbate Injection Due to Sterility Concerns
Medaus, Inc. is recalling 15,500 mL of Sodium Ascorbate 500 mg/mL injection due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.
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 microbial contamination of a sterile injectable product, which poses a risk of serious adverse health consequences such as infection.
Plain-English summary
Medaus, Inc. is recalling 15,500 mL of Sodium Ascorbate 500 mg/mL, PF, 100 mL vials. The affected product is identified by Lot # 130702-1 and has an expiration date of 12/29/2013. The recall was initiated because laboratory results from a contract testing lab indicated microbial contamination. Additionally, the FDA expressed concern that the test results obtained from the firm's contract lab may not be reliable, meaning the sterility of the products cannot be assured.
The product was distributed nationwide. This recall is classified as Class II by the FDA, indicating 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.
Consumers and healthcare providers should stop using the affected product and contact Medaus Pharmacy at 1-800-526-9183 for further instructions or a refund.
The recalled product
- Product
- NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable
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 # 130702-1
- Exp 12/29/2013
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.
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