FDA Recalls Unapproved Vitamin B12 Injections Due to Unregistered Manufacturer
Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin 5000 Injection USP because 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 classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the defect involves a structural or regulatory failure of a drug product.
Plain-English summary
Medical Supply Liquidators LLC is recalling Vitamin B12 Methylcobalamin 5000 Injection USP, 5000 mcg/ml, in 10 ml and 30 ml vials. The product is sterile and intended for intramuscular or deep subcutaneous use. The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), and the manufacturing firm is not registered with the FDA as a drug manufacturer.
The recall affects all lot numbers and expiration dates. The product was distributed nationwide and internationally to Canada, the United Kingdom, Australia, Slovenia, Germany, Spain, Finland, and Croatia. The product was manufactured by CB Inc. for Sunshine Labs.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance. The source text does not report any specific illnesses or injuries associated with the use of this product.
The recalled product
- Product
- Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, 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 Vitamin
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 →Related recalls
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