The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0352-2016·Announced 2015-11-25

Downing Labs Recalls Glucosamine HCL Injectable Due to Sterility Concerns

Downing Labs, LLC is recalling 20 vials of Glucosamine HCL Injectable because the product lacks assurance of sterility. The recall covers all lots distributed in the US and internationally.

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 rubric, an FDA Class II recall involving a structural defect or significant risk (lack of sterility in an injectable) corresponds to a Severe severity score (4), as it implies a risk of adverse health consequences that are not merely theoretical or cosmetic.

Plain-English summary

Downing Labs, LLC is recalling 20 vials of Glucosamine HCL Injectable, 200mg/mL, 30mL vial, Rx only. The recall is being conducted because the product lacks assurance of sterility. The affected product is distributed nationwide in the US and in several international locations, including Australia, Brazil, and Japan.

The recall covers all lots of the product. The source text does not specify specific lot numbers, expiration dates, or the exact number of units distributed. The product is a prescription-only injectable medication.

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

The recalled product

Product
Glucosamine HCL Injectable, 200mg/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
20

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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