The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-389-2013·Announced 2013-05-22

Green Valley Drugs Recalls Methylprednisolone and Dexamethasone Injections for Sterility Concerns

Green Valley Drugs is recalling Methylprednisolone and Dexamethasone Injections 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 involves a lack of sterility assurance, which poses a risk of serious infection, meeting the criteria for a Severe rating.

Plain-English summary

FVS Holdings, Inc. dba Green Valley Drugs is recalling Methylprednisolone and Dexamethasone Injection, all strengths and presentations, including Methylpred/Dexameth 1-2-3 mL and Methylpred/Dexa 3 mL PFS. The recall involves 430 vials and syringes distributed nationwide. Specific lot numbers and expiration dates are listed in the source metadata.

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 cited concerns associated with the facility's quality control processes as the reason for the action.

This is an FDA Class II recall. Patients who have received these injections should contact their healthcare provider for guidance on monitoring for potential infection or other adverse effects.

The recalled product

Product
Methylprednisolone and Dexamethasone Injection, all strengths and all presentations including a) Methylpred/ Dexameth 1-2-3 mL and b) Methylpred/Dexa 3 mL PFS; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Steroids
Hazard
Affected units
430

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) Methylpred/ Dexameth 1-2-3 mL: 13040150GV1
  • Exp 7/1/2013
  • 13032750GV3
  • Exp 6/27/2013
  • b) Methylpred/Dexa 3 mL PFS: 13032050GV4
  • Exp 6/20/2013

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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