The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-388-2013·Announced 2013-05-22

Green Valley Drugs Recalls Methylprednisolone and Marcaine Injections for Sterility Concerns

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 607 vials of Methylprednisolone Acetate and Marcaine Injection due to 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 under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 607 vials of Methylprednisolone Acetate and Marcaine Injection. The recall covers all strengths and presentations of the product, including specific combinations of Methylpred 80 mg/mL and Marcaine 0.25%-2.75, and Methylpred_Marc-0.25-0.27. The product is prescription-only and was distributed nationwide.

The recall was initiated 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 facility's quality control processes as the reason for the action.

Affected lot numbers include 130312200GV3 (Exp 6/12/13), 13011536 (Exp 4/15/2013), 20130226-GV2 (Exp 5/26/2013), 13012335GV4 (Exp 4/23/2013), and 13012460GV2 (Exp 4/24/2013). Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Methylprednisolone Acetate and Marcaine Injection, all strengths and all presentations including a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75, b) Methylpred_Marc-0.25-0.27, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Sterile Compounded
Hazard
Affected units
607

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 (10)

  • Lot#: a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75: 130312200GV3
  • Exp 6/12/13
  • b) Methylpred_Marc-0.25-0.27: 13011536
  • Exp 4/15/2013
  • 20130226-GV2
  • Exp 5/26/2013
  • 13012335GV4
  • Exp 4/23/2013
  • 13012460GV2
  • Exp 4/24/2013

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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