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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Category
- Drug — Injectable Steroids
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 →Related recalls
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FDA (Drugs) · 2013-05-22
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