The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-358-2013·Announced 2013-05-22

Green Valley Drugs Recalls Dexpanthenol Injection Due to Sterility Concerns

Green Valley Drugs is recalling 273 vials of Dexpanthenol Injection nationwide due to a lack of assurance of sterility and quality control concerns.

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 (4) under the rubric for drug recalls involving significant health risks like sterility failures.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 273 vials of Dexpanthenol Injection, prescription only, in all strengths and presentations. The affected products include Dexpanthenol 250 mg/30 mL, Dexpanthenol 250 mg/mL 10 mL, 30 mL, and 50 mL, and Dexpanthenol 250 mg/mL 10 mL P.F. 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. The FDA cited concerns associated with the quality control processes as the reason for the recall.

Affected lot numbers include 20130212-A (Exp 5/12/2013), 20130122-E (Exp 4/22/2013), and 20130212-D (Exp 5/12/2013). Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected products.

The recalled product

Product
Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250 mg/30 mL; Dexpanthenol 250 mg/mL 10 mL, 30 mL, 50 mL; and Dexpanthenol 250 mg/mL 10 mL P.F.; 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
273

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 #: 20130212-A
  • Exp 5/12/2013
  • 20130122-E
  • Exp 4/22/2013
  • 20130212-D

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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