FDA Recalls Unapproved Vitamin B12 Injection Vials
Medical Supply Liquidators LLC is recalling Vitamin B12 Hydroxocobalamin Injection vials 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 agency classification is FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the product is an injectable drug lacking required regulatory approvals.
Plain-English summary
Medical Supply Liquidators LLC is recalling Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, sterile, 30 ml vials. The product is intended for intramuscular or deep subcutaneous use and was manufactured by CB Inc. for Sunshine Labs.
The recall was initiated 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.
Distribution was made nationwide and to Canada, the United Kingdom, Australia, Slovenia, Germany, Spain, Finland, and Croatia. All lot numbers and expiration dates are affected. Consumers and healthcare providers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, 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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