The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0363-2016·Announced 2015-11-25

Downing Labs Recalls Calcium Gluconate Injection Due to Sterility Concerns

Downing Labs, LLC is recalling 286 vials of Calcium Gluconate Injection 10% because the company cannot ensure the product is sterile.

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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death if contaminated.

Plain-English summary

Downing Labs, LLC is voluntarily recalling 286 vials of Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, prescription only. The recall was initiated because the company lacks assurance of the sterility of the product.

The affected product was distributed nationwide in the United States and internationally to 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.

Healthcare providers and patients should stop using the recalled product and contact Downing Labs, LLC at 1-800-914-7435 for further instructions.

The recalled product

Product
Calcium Gluconate (680mOsm/L) Injection 10%, 50mL 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
286

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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