Downing Labs Recalls TNPRDC Injection Due to Sterility Concerns
Downing Labs, LLC is recalling 171 vials of TNPRDC Injection because the company cannot assure the sterility of the product. 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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Downing Labs, LLC is recalling 171 vials of TNPRDC Injection, a prescription-only medication packaged in 6 mL vials. The recall was initiated because the manufacturer lacks assurance of the sterility of the product. This issue affects all lots of the medication.
The affected product was distributed 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. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers and healthcare providers should stop using the recalled TNPRDC Injection and contact Downing Labs, LLC at 1-800-914-7435 for further instructions or to arrange for a return or replacement.
The recalled product
- Product
- TNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
- Manufacturer
- Downing Labs, LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 171
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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