Green Valley Drugs Recalls Methylprednisolone and Bupivacaine Injection Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Methylprednisolone and Bupivacaine Injection due to a lack of assurance of sterility and quality control concerns.
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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile medical injections.
Plain-English summary
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Methylprednisolone and Bupivacaine Injection, all strengths and presentations, including Methylpred80mg/bupivacaine0.25% syrup. The recall involves 52 syringes distributed nationwide. The specific lot numbers affected are 13012335-GV4 (Exp 4/23/2013), 20130226-GV2 (Exp 5/26/2013), and 130312200GV3 (Exp 6/12/2013).
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 noted concerns associated with the quality control processes at the facility.
Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Methylprednisolone and Bupivacaine Injection, all strengths and all presentations including Methylpred80mg/bupivacaine0.25% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Manufacturer
- FVS Holdings, Inc. dba. Green Valley Drugs
- Affected units
- 52
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 #: 13012335-GV4
- Exp 4/23/2013
- 20130226-GV2
- Exp 5/26/2013
- 130312200GV3
- Exp 6/12/2013
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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