US Compounding Recalls Dexamethasone Sodium Phosphate Vials Due to Sterility Concerns
US Compounding Inc is recalling 235 vials of Dexamethasone Sodium Phosphate PF due to deficient practices that may impact sterility assurance.
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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance for an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
US Compounding Inc is recalling 235 vials of Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use Only. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and carries the NDC 62295-3227-02. The specific lot number is 20151407@13 with a beyond-use date of 1/10/2016.
The recall was initiated because of a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry. The distribution of the affected product was nationwide.
Healthcare providers and patients should stop using the affected vials immediately. Consumers should check their medication for the specific lot number and beyond-use date listed above. If the product matches the recalled description, it should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or IM Use Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3227-02
- Manufacturer
- US Compounding Inc
- Affected units
- 235
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 (1)
- Lot Numbers: 20151407@13 BUD: 1/10/2016
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc 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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