Green Valley Drugs Recalls Estradiol Valerate Injection Due to Sterility Concerns
Green Valley Drugs is recalling Estradiol Valerate Injection vials because the pharmacy could not ensure the products were sterile. This affects 243 vials distributed nationwide.
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 agency classification is FDA Class II. The hazard involves a lack of sterility assurance for an injectable drug, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 243 vials of Estradiol Valerate Injection, prescription only. The recall covers all strengths and presentations, including Estradiol Valerate 40-10 mL and Estradiol Valerate 40-30 mL. The affected lot number is 20130114-B, with an expiration date of 4/14/2013.
The recall was initiated due to a lack of assurance of sterility. The source text indicates that all sterile products compounded, repackaged, and distributed by this compounding pharmacy are affected due to concerns associated with the quality control processes. The products were distributed nationwide.
Consumers and healthcare providers should stop using the affected Estradiol Valerate Injection vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Estradiol Valerate Injection, all strengths and all presentations including a) Estradiol Valerate 40-10 mL and b) Estradiol Valerate 40-30 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
- 243
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 #: 20130114-B
- Exp 4/14/2013
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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