Green Valley Drugs Recalls Phenylephrine Injection Due to Sterility Concerns
Green Valley Drugs is recalling Phenylephrine Injection vials because the pharmacy could not ensure the products were sterile.
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 injury or death from infection.
Plain-English summary
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 54 vials of Phenylephrine Injection, all strengths and presentations, including Phenylephrine 1% 30 mL. The recall is due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy.
The recall is based on concerns associated with the quality control processes at the facility. The affected lot number is 20130129-F, with an expiration date of 4/29/2013. The products were distributed nationwide.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Phenylephrine Injection, all strengths and all presentations including Phenylephrine 1% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Manufacturer
- FVS Holdings, Inc. dba. Green Valley Drugs
- Category
- Drug — Injectable
- Affected units
- 54
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 #: 20130129-F
- Exp 4/29/2013
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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