The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-959-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Furosemide Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling Furosemide 10 mg/mL injectable products because FDA inspectional findings raised concerns about sterility assurance.

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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization reports are rated as Severe (4). While the source does not explicitly state hospitalizations, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of harm consistent with the Severe classification for Class II recalls where the hazard is not merely theoretical or cosmetic.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., is recalling Furosemide 10 mg/mL injectable products. The recall covers all presentations of the sterile, prescription-only medication intended for intravenous and subcutaneous use, which was compounded by the pharmacy in Southfield, Michigan.

The recall was initiated due to FDA inspectional findings that resulted in concerns associated with quality control procedures impacting sterility assurance. The source text does not specify the number of units affected or the specific dates of distribution, though the distribution pattern is listed as USA nationwide.

Consumers and healthcare providers should stop using the recalled Furosemide 10 mg/mL injectable products and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
FUROSEMIDE 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
Manufacturer
Beacon Hill Medical Pharmacy, P.C.
Category
Drug — Injectable
Hazard

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)

  • 01162013@14
  • 02132013@18

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 →

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