The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-401-2013·Announced 2013-05-22

Green Valley Drugs Recalls Procaine Hydrochloride Injection Due to Sterility Concerns

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 70 vials of Procaine Hydrochloride Injection nationwide due to a lack of assurance of sterility in its compounding and 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant risk of harm, such as a lack of sterility assurance in injectable drugs, corresponds to a severity score of 4 (Severe).

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 70 vials of Procaine Hydrochloride Injection, available in various strengths and presentations, including Procaine 2% 30 mL PF, Procaine HCl 2% 10 mL, Procaine HCl 20 mg/mL 30 mL, Procaine HCl 1% 50 mL MDV, and Procaine HCl 1% PF 5 mL and 30 mL. The affected product is identified by Lot # 20130405-B with an expiration date of 7/5/2013. The recall is being conducted nationwide.

The recall is due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. This issue stems from concerns associated with the company's quality control processes. The FDA has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions on how to return or dispose of the medication.

The recalled product

Product
Procaine Hydrochloride Injection, all strengths and all presentations, including a) Procaine 2% 30 mL PF, b) Procaine HCl 2% 10 mL, c) Procaine HCl 20 mg/mL 30 mL, d) Procaine HCl 1% 50 mL MDV, e) Procaine HCl 1% PF 5 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa…
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable
Hazard
Affected units
70

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 #: a) 20130405-B
  • Exp 7/5/2013

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 →

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