Medaus Recalls Taurine Vials Due to Lack of Sterility Assurance
Medaus, Inc. is recalling Taurine 50 mg/mL vials because the company cannot assure the product is sterile.
What this means for you
Illness, injury, or structural failure has been reported. 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 the hazard involves a lack of sterility assurance for a parenteral product, which poses a risk of serious injury.
Plain-English summary
Medaus, Inc. is recalling Taurine 50 mg/mL (PF) in 1 mL, 10 mL, and 20 mL vials. The recall is being conducted because the company lacks assurance of the sterility of the affected product.
The affected lots are 151202-54 (Best Use Date: 05/30/16) and 160308-31 (Best Use Date: 09/04/16). The total quantity involved is 5,500 mL in vials. The product was distributed nationwide in the United States, as well as in Japan and New Zealand.
Consumers and healthcare providers should stop using the recalled product and contact Medaus, Inc. for further instructions or a return.
The recalled product
- Product
- TAURINE 50 MG/ML (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Parenteral
- Hazard
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 (6)
- a) Lot #: 151202-54
- BUD: 05/30/16
- Lot #: 160308-31
- BUD: 09/04/16. b) Lot #: 151202-54
- BUD: 09/04/16. c) Lot #: 151202-54
- BUD: 09/04/16.
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.
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