Medaus Recalls L-Glutathione Injection Due to Sterility Concerns
Medaus, Inc. is recalling L-Glutathione 200 mg/mL PF, 100 mL, 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 a risk of serious health consequences (microbial contamination/sterility failure) for a drug product, which aligns with the 'Severe' criteria for significant injury risk or Class II drug recalls with potential for serious harm.
Plain-English summary
Medaus, Inc. is recalling L-Glutathione 200 mg/mL PF, 100 mL, manufactured by Medaus Pharmacy. The recall affects Lot # 130617-10, which has an expiration date of 12/14/2013. The total quantity involved is 6130 mL, and the product was distributed nationwide.
The recall was initiated because laboratory results from a contract lab indicated microbial contamination. The FDA expressed concern that 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
- L-Glutathione 200 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 # 130617-10
- Exp 12/14/2013
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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