Agency classClass IIOur severity:Severe FDA (Drugs)·D-1532-2014·Announced 2014-08-13

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard: unapproved-drug
unregistered-manufacturer

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.

See all 15 products in this recall →

Same manufacturer · Medical Supply Liquidators Llc

See all →

Moderate
FDA Recalls Unapproved Vitamin B12 Injection Vials Nationwide
FDA (Drugs) · 2014-08-13
Severe
BCAA 4% Injection Recalled for Lack of FDA Approval
FDA (Drugs) · 2014-08-13
Severe
FDA Recalls Unapproved Vitamin B6 Injection Vials Nationwide
FDA (Drugs) · 2014-08-13
Moderate
FDA Recalls Unapproved Vitamin B12 Injection Vials Nationwide and Abroad
FDA (Drugs) · 2014-08-13
Moderate
FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer
FDA (Drugs) · 2014-08-13

Same hazard · unapproved drug