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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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.
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