The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-376-2013·Announced 2013-05-22

Green Valley Drugs Recalls Ketorolac Injection Due to Sterility Concerns

Green Valley Drugs is recalling 3,289 vials of Ketorolac 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 recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance in injectable medications, which poses a significant risk of serious injury or infection.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 3,289 vials of Ketorolac Injection, all strengths and presentations, including 10 mL multi-dose vials, 2 mL single-dose vials, and 1 mL single-dose vials. The affected products are prescription-only and were distributed nationwide.

The recall was initiated due to a lack of assurance of sterility in all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA identified concerns associated with the facility's quality control processes that compromised the sterility of the products.

Patients and healthcare providers should stop using the affected vials immediately. The specific lot numbers and expiration dates for the recalled products are: Ketorolac 30 mg/mL 10 mL (Lot 20130327-B, Exp 6/27/2013) and Ketorolac 30 mg/mL 2 mL (Lot 20130326-B, Exp 6/26/2013; Lot 20130307-C, Exp 6/7/2013).

The recalled product

Product
Ketorolac Injection, all strengths and all presentations including a) Ketorolac 30 mg/mL 10 mL MDV, b) Ketorolac 30 mg/mL 2 mL SDV, c) Ketorolac 30 mg/mL 1 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
3,289

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 (6)

  • Lot #: a) Ketorolac 30 mg/mL 10 mL: 20130327-B
  • Exp 6/27/2013
  • b) Ketorolac 30 mg/mL 2 mL: 20130326-B
  • Exp 6/26/2013
  • 20130307-C
  • Exp 6/7/2013

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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