Medaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns
Medaus, Inc. is recalling Testosterone Cypionate vials because the company cannot guarantee the product is sterile.
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 lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Medaus, Inc. is recalling Testosterone Cypionate 100 mg/mL with preservative (Benzyl Ethyl Alcohol 2%) in 1 mL, 2 mL, 3 mL, and 5 mL vials. The recall is being conducted because the company lacks assurance of the sterility of the product.
The affected product is identified by Lot # 160115-17 with an expiration date of 07/13/16. The recall covers distribution in the United States, Japan, and New Zealand.
Consumers and healthcare providers should stop using the affected product and contact Medaus, Inc. for further instructions or a refund.
The recalled product
- Product
- TESTOSTERONE CYP 100 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, and d) 5 ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable Steroids
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 (5)
- a) Lot #: 160115-17
- BUD: 07/13/16. b) Lot #: 160115-17
- BUD: 07/13/16. c) Lot #: 160115-17
- BUD: 07/13/16. d) Lot #: 160115-17
- BUD: 07/13/16.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 88 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 88 products in this recall →Related recalls
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