The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-993-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls PUMICE/LIDOCAINE HCL Injection Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling PUMICE/LIDOCAINE HCL 1.5%/1% Injection Suspensions because FDA inspections 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 high-risk contexts (like sterility failure in injectables) align with a Severe rating, and the rule states FDA Class I/II should not go below 4 if significant risks are present, though strictly Class II is often 3-4. Given the 'Lack of Assurance of Sterility' for an IV/SQ product, this poses a significant risk of serious injury (sepsis), fitting the 'Severe' criteria for significant injury reports or high-risk structural/quality defects.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions in Southfield, Michigan, is recalling all presentations of PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP. The product is a sterile, prescription-only injection suspension intended for intravenous and subcutaneous use only.

The recall was initiated following FDA inspectional findings that identified concerns associated with quality control procedures. These findings specifically impacted the assurance of sterility for the compounded product.

The recall covers distribution across the USA nationwide. Patients who have received this medication should contact their healthcare provider for guidance on next steps.

The recalled product

Product
PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP, 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 — Compounded 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 (1)

  • 05202013@20

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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