Medaus Recalls Taurine 50 mg/mL PF Due to Sterility Concerns
Medaus, Inc. is recalling Taurine 50 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 microbial contamination of a sterile product, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Medaus, Inc. is recalling Taurine 50 mg/mL PF, 100 mL, manufactured by Medaus Pharmacy. The recall involves 1,660 mL of the product, specifically Lot # 130618-64 with a beyond-use date of 12/15/2013. The product was distributed nationwide.
The recall was initiated due to laboratory results from a contract lab indicating 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 or a refund.
The recalled product
- Product
- Taurine 50 mg/mL PF, 100 mL, 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 # 130618-64
- BUD: 12/15/2013
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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