Downing Labs Recalls Acetyl-L-Carnitine Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling Acetyl-L-Carnitine and L-Carnitine injectable vials due to a lack of assurance of sterility. The products were 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 significant hazard such as lack of sterility in an injectable product corresponds to a severity score of 4 (Severe).
Plain-English summary
Downing Labs, LLC is recalling 108 vials of Acetyl-L-Carnitine Injectable (100mg/mL, 30mL) and L-Carnitine Injection (500mg/mL, 30mL). The recall was initiated because of a lack of assurance of sterility in the products. These are prescription-only medications.
The affected products were 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 covers all lots of the specified products.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider for further instructions. Downing Labs, LLC can be reached at 1-800-914-7435 for additional information.
The recalled product
- Product
- Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/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
- 108
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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