The Recall Desk
SevereFDA (Drugs)·D-398-2013·Announced 2013-05-22

Green Valley Drugs Recalls Phenylephrine Injection Due to Sterility Concerns

Green Valley Drugs is recalling Phenylephrine Injection vials because the pharmacy could not ensure the products were sterile.

What this means for you

Illness, injury, or structural failure has been reported. 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 sterility assurance for injectable drugs, which poses a significant risk of serious injury or death from infection.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 54 vials of Phenylephrine Injection, all strengths and presentations, including Phenylephrine 1% 30 mL. The recall is due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy.

The recall is based on concerns associated with the quality control processes at the facility. The affected lot number is 20130129-F, with an expiration date of 4/29/2013. The products were distributed nationwide.

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
Phenylephrine Injection, all strengths and all presentations including Phenylephrine 1% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Affected units
54

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 (2)

  • Lot #: 20130129-F
  • Exp 4/29/2013

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 →