The Recall Desk
SevereFDA (Drugs)·D-1240-2016·Announced 2016-07-20

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, which corresponds to a Severe severity score under the rubric for potential serious temporary health consequences.

Plain-English summary

Medaus, Inc. is recalling Taurine 50 mg/mL with preservative (benzalkonium chloride 0.01%) in 10 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 # 160315-4 with a beyond-use date of 05/30/16. The product was distributed to pharmacies in the United States, Japan, and New Zealand.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
TAURINE 50 MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Pharmaceutical
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 (2)

  • Lot #: 160315-4
  • BUD: 05/30/16

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

Same manufacturer · Medaus, Inc.

See all →

Same hazard · lack of sterility

See all →