Downing Labs Recalls TNPDR Injection Buffered Due to Sterility Concerns
Downing Labs, LLC is recalling 481 vials of TNPDR Injection Buffered because the company cannot ensure the product is sterile. The recall covers all lots distributed nationwide 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 risk of serious injury (lack of sterility in an injectable) corresponds to a Severe rating (Score 4), particularly given the potential for significant injury from non-sterile injections.
Plain-English summary
Downing Labs, LLC is recalling 481 vials of TNPDR Injection Buffered, a prescription-only medication. The recall is being conducted because the company lacks assurance of the product's sterility. The affected product is distributed in 30mL vials.
The recall includes all lots of the product. Distribution was nationwide in the United States 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.
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
- TNPDR Injection Buffered, 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
- 481
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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