The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-977-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Magnesium Sulfate Injectable Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling all presentations of Magnesium Sulfate 50% Injectable due to FDA inspectional findings regarding quality control and 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 with potential for adverse health consequences (such as sterility failure in an injectable) are classified as Severe (Score 4), particularly given the strict rule that FDA Class I or USDA Class I never go below 4, and Class II with significant risk factors aligns with Severe.

Plain-English summary

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

The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures. Specifically, the inspection identified issues that impacted the assurance of sterility for the compounded injectable product. The source text does not specify the number of units affected or report any illnesses or injuries associated with the use of the product.

Healthcare providers and patients should stop using the affected Magnesium Sulfate 50% Injectable products and contact the recalling firm or their healthcare provider for further instructions. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
MAGNESIUM SULFATE 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
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 (3)

  • 01082013@14
  • 02182013@5
  • and 06052013@29

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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