The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-953-2013·Announced 2013-09-18

Beacon Hill Medical Pharmacy Recalls EDETATE DISODIUM INJECTABLE Due to Sterility Concerns

Beacon Hill Medical Pharmacy is recalling EDETATE DISODIUM 150 MG/ML INJECTABLE because FDA inspectional findings raised concerns about quality control procedures impacting 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 and involves a lack of assurance of sterility in an injectable drug, which poses a risk of serious health consequences such as infection.

Plain-English summary

Beacon Hill Medical Pharmacy, P.C., dba Rxtra Solutions, is recalling EDETATE DISODIUM 150 MG/ML INJECTABLE, all presentations, for intravenous and subcutaneous use only. The product is sterile, prescription-only, and was compounded by the pharmacy in Southfield, MI.

The recall was initiated due to a lack of assurance of sterility. FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. The agency has classified this recall as Class II.

The affected product was distributed nationwide in the USA. Specific lot codes associated with the recall include 07172013@4, 01222013@14, 03072013@10, 04032013@1, 05162013@17, 06042013@30m, 07092013@17, and 07262013@2. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
EDETATE DISODIUM 150 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 (8)

  • 07172013@4
  • 01222013@14
  • 03072013@10
  • 04032013@1
  • 05162013@17
  • 06042013@30m
  • 07092013@17
  • and 07262013@2

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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