Downing Labs Recalls L-Tryptophan Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling 16 vials of L-Tryptophan Injectable because the company cannot assure the product's sterility.
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, FDA Class II recalls involving significant injury or property damage reports, or in this case a critical sterility failure in an injectable drug, are categorized as Severe.
Plain-English summary
Downing Labs, LLC is recalling 16 vials of L-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only. The recall is being conducted because the company lacks assurance of the product's sterility.
The affected product was distributed nationwide in the US 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. All lots are included in this recall.
Consumers and healthcare providers should stop using the product and contact Downing Labs, LLC at 1-800-914-7435 for further instructions.
The recalled product
- Product
- L-Tryptophan Injectable, 30mg/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
- 16
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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