The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1018-2013·Announced 2013-09-18

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

Beacon Hill Medical Pharmacy is recalling Manganese Sulfate 0.1 mg/mL Injectable due to FDA inspectional findings regarding 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. Per the rubric, FDA Class II recalls involving significant safety concerns such as sterility assurance failures in injectable products are rated as Severe.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., doing business as Rxtra Solutions, is recalling Manganese Sulfate 0.1 mg/mL Injectable. The product is sterile, prescription-only, and intended for intravenous and subcutaneous use. The recall covers all configurations of the product.

The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures. Specifically, the findings impacted the assurance of sterility for the compounded injectable product.

The recall is distributed nationwide in the United States. Patients who have received this medication should contact their healthcare provider for guidance on next steps.

The recalled product

Product
MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, 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)

  • 01212013@8
  • 04042013@15 and 06272013@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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