The Recall Desk
SevereFDA (Drugs)·D-0343-2016·Announced 2015-11-25

Downing Labs Recalls MICML TRNDPPC Injection Due to Sterility Concerns

Downing Labs, LLC is recalling MICML TRNDPPC Injection (Preserved) 10mL vials because the company cannot ensure 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 FDA classified this recall as Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks such as sterility issues in injectable products.

Plain-English summary

Downing Labs, LLC is recalling 502 vials of MICML TRNDPPC Injection (Preserved) 10mL vials. The recall is being conducted because the company lacks assurance of the sterility of the product. The affected 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.

The recall covers all lots of the product. The FDA has classified this recall as Class II, indicating 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 product and contact Downing Labs, LLC at 1-800-914-7435 for further instructions on how to return the product.

The recalled product

Product
MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Manufacturer
Downing Labs, LLC
Category
Drug — Injection
Hazard
Affected units
502

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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