The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-960-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls Compounded Glutamine Injection Solution

Beacon Hill Medical Pharmacy is recalling compounded glutamine injection solution due to FDA inspectional findings regarding sterility assurance and quality control.

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, which corresponds to a Severe rating under the rubric, particularly given the risk of sterility failure in an injectable medication.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., dba Rxtra Solutions, is recalling all presentations of GLUTAMINE 100 MG/ML INJ SOLN. The product is a sterile, prescription-only compounded solution intended for intravenous and subcutaneous use only. The recall is being conducted due to FDA inspectional findings that raised concerns about quality control procedures impacting sterility assurance.

The recall covers the product distributed nationwide in the United States. The specific reason for the recall is a lack of assurance of sterility resulting from the identified quality control issues. No specific lot numbers, dates, or affected unit counts are provided in the source text.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions or replacement.

The recalled product

Product
GLUTAMINE 100 MG/ML INJ SOLN, 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)

  • 06262013@22

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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