The Recall Desk
SevereFDA (Drugs)·D-1523-2014·Announced 2014-08-13

FDA Recalls Unapproved Vitamin B6 Injection Vials Nationwide

Medical Supply Liquidators LLC is recalling Vitamin B6 Pyridoxine HCL for Injection 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 for significant regulatory non-compliance involving injectable drugs.

Plain-English summary

Medical Supply Liquidators LLC is recalling Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, sterile, multiple-dose 30 ml vials. 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 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 product is intended for intramuscular (IM) or deep subcutaneous (SQ) use.

Distribution was made nationwide and to foreign countries including 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
Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us.

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 →