The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-367-2013·Announced 2013-05-22

Green Valley Drugs Recalls Furosemide Injection Due to Sterility Concerns

Green Valley Drugs is recalling Furosemide Injection vials because the pharmacy could not ensure the products were sterile. The recall covers 227 vials distributed nationwide.

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 severity score under the rubric. The hazard involves a lack of sterility assurance for an injectable drug, which poses a significant risk of infection or serious injury.

Plain-English summary

FVS Holdings, Inc. dba Green Valley Drugs is recalling 227 vials of Furosemide Injection, all strengths and presentations. The affected products include Furosemide PF-10 mg-10 mL, Furosemide PF-10 mg-2 mL SDV, and Furosemide 10 mg/mL 4 mL SDV. These prescription-only medications were 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. The company cited concerns associated with its quality control processes as the reason for the inability to guarantee sterility.

Consumers and healthcare providers should stop using the recalled Furosemide Injection vials and contact their healthcare provider or pharmacist for guidance on alternative treatments or replacements. The specific lot numbers and expiration dates for the affected products are listed in the recall documentation.

The recalled product

Product
Furosemide Injection, all strengths and all presentations including a) Furosemide PF-10 mg-10 mL, b) Furosemide PF-10 mg-2 mL SDV, and Furosemide 10 mg/mL 4 mL SDV, 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 (4)

  • Lot #: a) Furosemide PF-10 mg-10 mL: 20130201-F
  • Exp 5/1/2013
  • b) Furosemide PF-10 mg-2 mL SDV: 20130306-F
  • Exp 6/6/2013.

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 · lack of sterility

See all →

Similar recalls