The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-344-2013·Announced 2013-05-22

Green Valley Drugs Recalls Bacteriostatic Water for Injection Due to Sterility Concerns

Green Valley Drugs is recalling Bacteriostatic Water for Injection because the company cannot ensure the products are sterile.

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. According to the rubric, an FDA Class II recall involving a sterile product with quality control concerns regarding sterility assurance falls under the 'Severe' category (Score 4), as it poses a significant risk of harm.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only. The recall involves 597 vials distributed nationwide. The specific lots affected are 20130122-C (Exp 4/22/2013), 20130122-D (Exp 4/22/2013), and 20130319-A (Exp 6/19/2013).

The recall was initiated due to a lack of assurance of sterility. The FDA notes that all sterile products compounded, repackaged, and distributed by this compounding pharmacy are affected due to lack of sterility assurance and concerns associated with the quality control processes.

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

The recalled product

Product
Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Sterile Injection
Hazard
Affected units
597

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 (5)

  • Lot #: 20130122-C
  • Exp 4/22/2013
  • 20130122-D
  • 20130319-A
  • Exp 6/19/2013

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 · sterility failure

See all →

Similar recalls