The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0342-2016·Announced 2015-11-25

Downing Labs Recalls Ascorbic Acid Injectable Due to Sterility Concerns

Downing Labs, LLC is recalling Ascorbic Acid Injectable 500mg/mL vials due to a lack of assurance of sterility. The recall affects 4,857 vials distributed in the US and 17 other countries.

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. According to the severity rubric, an FDA Class II recall with potential for adverse health consequences (such as sterility issues in injectables) corresponds to a score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but involves a significant risk of harm.

Plain-English summary

Downing Labs, LLC is recalling Ascorbic Acid Injectable 500mg/mL, packaged in 10mL, 50mL, and 100mL vials. The recall is being conducted due to a lack of assurance of sterility. The affected 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 involves 4,857 vials across all lots. 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 for further instructions. Downing Labs, LLC can be reached at 1-800-914-7435 for additional information regarding the recall.

The recalled product

Product
Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, 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
4,857

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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