Downing Labs Recalls DMSO 99% Injection Due to Sterility Concerns
Downing Labs, LLC is recalling DMSO 99% Injection vials because the product lacks assurance of sterility. The recall affects 187 vials distributed in the US and internationally.
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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable product is rated as Severe (4).
Plain-English summary
Downing Labs, LLC is recalling 187 vials of DMSO 99% Injection, 50mL vial, Rx only. The recall was initiated because the product lacks assurance of sterility. The affected product is distributed nationwide in the US and in several international locations, including 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. Consumers and healthcare providers should stop using the recalled product and contact Downing Labs, LLC at 1-800-914-7435 for further instructions.
The recalled product
- Product
- DMSO 99% Injection, 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
- 187
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.
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