The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-393-2013·Announced 2013-05-22

Green Valley Drugs Recalls Methylprednisolone Acetate Injection Due to Sterility Concerns

Green Valley Drugs is recalling Methylprednisolone Acetate Injection products because the company could not ensure the sterility of the compounded and repackaged items.

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 for injectable drugs, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Methylprednisolone Acetate Injection, including all strengths and presentations such as 40 mg/mL and 80 mg/mL vials and syringes. The recall involves 4,350 units distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The source text indicates that all sterile products compounded, repackaged, and distributed by this compounding pharmacy are affected due to concerns associated with the quality control processes.

Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for further instructions. The FDA has classified this recall as Class II.

The recalled product

Product
Methylprednisolone Acetate Injection, all strengths and all presentations including a) Methylprednisolone Acetate 40 mg/mL, b) Methylprednisolone Acetate (PF) 40 mg/mL, c) Methylprednisolone Acetate (PF) 80 mg/mL, d) Methylpred Acetate 40 mg/mL 1 mL, e) Methylprednisolone 80…
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Steroids
Hazard
Affected units
4,350

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 (20)

  • a) Methylprednisolone Acetate 40 mg/mL: 20130228-E
  • Exp 5/28/2013
  • 2013012370-GV3
  • Exp 4/23/2013
  • 20130318-D
  • Exp 6/18/2013
  • b) Methylprednisolone Acetate (PF) 40 mg/mL: 20130219-B
  • Exp 5/19/2013
  • 20130315-B
  • Exp 6/15/2013
  • c) Methylprednisolone Acetate (PF) 80 mg/mL: 201303131-A
  • Exp 6/13/2013
  • 20130304-M
  • Exp 6/4/2013
  • 20130405-A
  • Exp 7/5/2013
  • 20130214-G
  • Exp 5/14/2013
  • d) Methylpred Acetate 40 mg/mL 1 mL: 20130318-D
  • e) Methylprednisolone 80 mg/5 mL: 20130214-G

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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