Medaus Recalls Testosterone Cyp 200 mg/mL Due to Sterility Concerns
Medaus, Inc. is recalling Testosterone Cyp 200 mg/mL injections because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.
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 (sepsis/infection) due to lack of sterility assurance in an injectable drug, meeting the criteria for a Severe rating.
Plain-English summary
Medaus, Inc. is recalling Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL vials. The recall involves 1,198 mL of the product, specifically Lot # 130508-1 with a best-use date of 11/16/2013. The product was distributed nationwide.
The recall was initiated due to laboratory results from a contract testing lab indicating microbial contamination. The FDA expressed concern that the test results obtained from the recalling firm's contract lab may not be reliable. Consequently, 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
- Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable Steroid
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 # 130508-1
- BUD: 11/16/2013
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 →Related recalls
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