The Recall Desk
CriticalFDA (Drugs)·D-321-2013·Announced 2013-05-22

Green Valley Drugs Recalls Methylprednisolone Injectable Suspension Due to Sterility Failure

Green Valley Drugs is recalling Methylprednisolone Preservative Free 40 mg/mL injectable suspension because testing revealed positive sterility results.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Green Valley Drugs is recalling specific lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension. The recall was initiated after the company's testing laboratory reported positive sterility results for two lots of the product.

The affected products include 1 mL vials, 2 mL vials, and 1 mL pre-filled syringes intended for office use only. The recall covers 1,395 vials in total, consisting of 900 1 mL vials from lot 20121105-B, 90 2 mL vials from lot 20121112-G, and 495 1 mL vials from lot 20121112-G. The products were distributed nationwide.

The source text notes that the company also received positive sterility results for one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV, though the primary recall notice focuses on the Methylprednisolone suspension. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer or their supplier for further instructions.

The recalled product

Product
Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL pre-filled syringes, For Office Use Only, Manufactured by Green Valley Drugs, Henderson, NV.
Manufacturer
Green Valley Drugs

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 (2)

  • Lot #s: 20121105-B
  • 20121112-G

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by 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 2 products in this recall →

Same manufacturer · Green Valley Drugs

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