The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0380-2016·Announced 2015-11-25

Downing Labs Recalls Potassium Chloride Injection Due to Sterility Concerns

Downing Labs, LLC is recalling 225 vials of Potassium Chloride Injection due to a lack of assurance of sterility. The product was distributed nationwide and in multiple international markets.

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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a sterile injectable product where sterility is not assured is categorized as Severe (Score 4), as it carries a risk of serious adverse health consequences such as infection.

Plain-English summary

Downing Labs, LLC is recalling 225 vials of Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial. The recall is being conducted because of a lack of assurance of sterility. The product is prescription-only and was distributed nationwide in the United States 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 affected product. No specific lot numbers are provided in the source text. 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.

Healthcare providers and patients should stop using the recalled product and contact Downing Labs, LLC at 1-800-914-7435 for further instructions or to arrange for a return or replacement. Consumers should not attempt to use the product if they have any concerns about its sterility.

The recalled product

Product
Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 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 — Injectable
Hazard
Affected units
225

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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