Agency classClass IIOur severity:Severe FDA (Drugs)·D-1528-2014·Announced 2014-08-13

B Complex Injection Recalled for Lack of FDA Approval

Medical Supply Liquidators LLC is recalling B Complex for Injection USP with Methylcobalamin because it was marketed without an approved NDA/ANDA and the manufacturer is not FDA-registered.

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 classification is FDA Class II, which corresponds to a Severe severity score (4) according to the rubric, as it involves a product that may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Medical Supply Liquidators LLC is recalling B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, sterile, for IM or deep SQ use. The product is packaged in 10 ml and 30 ml multiple-dose vials 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. The recall covers all lot numbers and expiration dates.

Distribution was nationwide and included foreign markets in 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: B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. 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

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