The Recall Desk
SevereFDA (Drugs)·D-947-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Dexamethasone Sodium Phosphate Injectable

Beacon Hill Medical Pharmacy is recalling Dexamethasone Sodium Phosphate 10 mg/mL injectable due to sterility assurance concerns identified during an FDA inspection.

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. The hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling Dexamethasone Sodium Phosphate 10 mg/mL injectable. The product is available in all presentations and is intended for intravenous and subcutaneous use only. It is a sterile, prescription-only compounded medication.

The recall was initiated because FDA inspectional findings raised concerns regarding quality control procedures that impacted the assurance of sterility. 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 instructions on how to proceed. Consumers should not use the product until further notice.

The recalled product

Product
DEXAMETHASONE SODIUM PHOSPHATE 10 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 (3)

  • 01162013@13
  • 05202013@23
  • 07112013@11

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 →