Green Valley Drugs Recalls Betamethasone Sodium Phosphate Injection Due to Sterility Concerns
Green Valley Drugs is recalling Betamethasone Sodium Phosphate Injection because the pharmacy could not ensure the sterility of the compounded products.
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, which corresponds to a Severe severity score (4) under the rubric, particularly given the risk of infection from non-sterile injectable products.
Plain-English summary
FVS Holdings, Inc. dba Green Valley Drugs is recalling Betamethasone Sodium Phosphate Injection in all strengths and presentations, including 6 mg/2 mL PF and 6 mg/mL. The recall involves 65 vials distributed nationwide. The specific lots affected are 20130405-F (Exp 7/5/2013) and 20130222-A (Exp 5/22/2013).
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 identified concerns associated with the quality control processes at the facility.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Betamethasone Sodium Phosphate Injection, all strengths and all presentations including 6 mg/2 mL PF and 6 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
- Manufacturer
- FVS Holdings, Inc. dba. Green Valley Drugs
- Category
- Drug — Injectable Steroid
- Affected units
- 65
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 (5)
- Lot #: 20130405-F
- Exp 7/5/2013
- 20130222-A
- Exp 5/22/2013
- 20130405-F
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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