The Recall Desk
SevereFDA (Drugs)·D-949-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Dextrose PF 50% Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Dextrose PF 50% Injectable because FDA inspections raised concerns about 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Dextrose PF 50% Injectable. The recall covers all presentations of the sterile, prescription-only medication intended for intravenous and subcutaneous use. The product was distributed nationwide in the United States.

The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. The agency has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions. The recall is identified by FDA recall number D-949-2013.

The recalled product

Product
DEXTROSE PF 50% 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)

  • 05202013@11
  • 07092013@19

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 →