The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-362-2013·Announced 2013-05-22

Green Valley Drugs Recalls Edetate Calcium Disodium Injection for Sterility Concerns

Green Valley Drugs is recalling Edetate Calcium Disodium Injection due to a lack of assurance of sterility in its quality control processes.

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 the hazard involves a lack of sterility assurance for injectable products, which poses a significant risk of serious injury or hospitalization.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Edetate Calcium Disodium Injection, all strengths and presentations, including 300 mg/mL 100 mL, 300-30 mL, and 200 mg/mL 15 mL vials. The recall involves 227 vials distributed nationwide.

The recall was initiated due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. This decision was made in response to concerns associated with the facility's quality control processes.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Edetate Calcium Disodium Injection, all strengths and all presentations including a) Edetate Calcium Disodium 300 mg/mL 100 mL, b) Edetate Calcium Disodium 300-30 mL, c) Calcium Edetate 200 mg/mL 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable
Hazard
Affected units
227

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)

  • Lot #: a) Edatate Calcium Disodium 300 mg/mL 100mL: 20130319-H
  • Exp 6/19/2013
  • 2010318-N
  • Exp 6/18/2013
  • b) Edetate Calcium Disodium 300-30 mL: 20130205-H
  • Exp 5/5/2013
  • 20130318-N
  • 20130319-H

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 78 recalled by FVS Holdings, Inc. dba. Green Valley Drugs 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 78 products in this recall →

Related recalls

Same manufacturer · FVS Holdings, Inc. dba. Green Valley Drugs

See all →

Same hazard · sterility

See all →

Similar recalls