L-Carnitine Injection Recalled for Lack of FDA Approval and Registration
Medical Supply Liquidators LLC is recalling L-Carnitine Injection USP 100 mg/ml because it was marketed without an approved NDA/ANDA and the manufacturer is not registered with the FDA.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe).
Plain-English summary
Medical Supply Liquidators LLC is recalling L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, for intramuscular or deep subcutaneous use. The product was manufactured by CB Inc. for Sunshine Labs. The recall covers all lot numbers and expiration dates.
The recall was initiated because the injectable products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the manufacturing firm is not registered with the FDA as a drug manufacturer.
The product was distributed nationwide and to Canada, the United Kingdom, Australia, Slovenia, Germany, Spain, Finland, and Croatia. Consumers and healthcare providers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
- Manufacturer
- Medical Supply Liquidators Llc
- Category
- Drug — Injectable
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 lot numbers and exp dates
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Medical Supply Liquidators 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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