US Compounding Recalls Dex LA 8 Vials Due to Sterility Assurance Concerns
US Compounding Inc is recalling 4,333 vials of Dex LA 8 (Dexamethasone acetate) nationwide because deficient practices may have impacted 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility assurance failures in injectable drugs) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.
Plain-English summary
US Compounding Inc is recalling 4,333 vials of Dex LA 8 (Dexamethasone acetate 8 mg/mL, 10 mL Multi-Dose Vial). The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and is distributed nationwide. The recall covers specific lots with expiration dates ranging from September 2015 to January 2016.
The recall was initiated due to 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 source text does not report any specific illnesses or injuries associated with the use of these products.
Healthcare providers and patients should stop using the affected vials and contact US Compounding Inc for further instructions. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3299-02
- Manufacturer
- US Compounding Inc
- Category
- Drug — Sterile Injectable
- Hazard
- Affected units
- 4,333
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 Numbers: 20150107@23 BUD: 12/28/2015
- 20151305@43 BUD: 11/9/2015
- 20151307@18 BUD: 1/9/2016
- 20152204@33 BUD: 10/19/2015
- 20152606@1 BUD: 12/22/2015
- 20153003@34 BUD: 9/26/2015
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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