The Recall Desk
HighFDA (Drugs)·D-0349-2016·Announced 2015-11-25

Downing Labs Recalls Taurine Injectable Due to Sterility Concerns

Downing Labs, LLC is recalling Taurine Injectable, 50mg/mL, 30mL vials due to a lack of assurance of sterility. The recall affects 123 vials distributed nationwide and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II due to a lack of assurance of sterility, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Downing Labs, LLC is recalling 123 vials of Taurine Injectable, 50mg/mL, 30mL vials. The recall is being conducted because of a lack of assurance of sterility. The product is prescription-only and was distributed nationwide in the US as well as in Australia, Brazil, the Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, the Philippines, Singapore, Thailand, Trinidad and Tobago, and Taiwan.

All lots of the product are affected. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. Downing Labs, LLC can be reached at 1-800-914-7435.

The recalled product

Product
Taurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Manufacturer
Downing Labs, LLC
Category
Drug — Injectable
Hazard
Affected units
123

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 (1)

  • All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 48 recalled by Downing Labs, LLC 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 48 products in this recall →

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