The Recall Desk
SevereFDA (Drugs)·D-994-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Pyridoxine HCL Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Pyridoxine HCL Injectable due to FDA inspectional findings regarding quality control and sterility assurance.

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, and the hazard involves a lack of assurance of sterility in an injectable product, which aligns with the rubric criterion for Severe recalls involving significant injury risks or Class II classifications with potential for serious harm.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Pyridoxine HCL P/F 100 MG/ML Injectable. The product is compounded for intravenous and subcutaneous use only and is sterile, prescription-only medication. The recall covers all presentations of the product.

The recall was initiated due to FDA inspectional findings that raised concerns associated with quality control procedures impacting sterility assurance. The source text does not specify the number of units affected, specific lot numbers beyond the provided codes, or the exact distribution dates.

Healthcare providers and patients who have received this product should contact their healthcare provider or the recalling firm for further instructions. The source text does not provide specific contact information or a return address.

The recalled product

Product
PYRIDOXINE HCL P/F 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

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 (2)

  • 03262013@2
  • 06252013@16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 86 recalled by Beacon Hill Medical Pharmacy, P.C. 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 86 products in this recall →