Unapproved Injectable B Complex Recall Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Super MIC B Complex injections because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.
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, which corresponds to a Severe severity score under the rubric for significant health risks or regulatory violations involving injectable products.
Plain-English summary
Medical Supply Liquidators LLC is recalling Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml. The product is a sterile, multiple-dose vial intended for intramuscular (IM) or deep subcutaneous (SQ) use. It was manufactured by CB Inc. for Sunshine Labs.
The recall is being conducted because the product was 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 recall covers all lot numbers and expiration dates.
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
- Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, 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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