US Compounding Recalls Hyaluronidase PF Vials Due to Sterility Concerns
US Compounding Inc is recalling 1,096 vials of Hyaluronidase PF (150 units/mL) nationwide 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 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 products) are categorized as Severe (Score 4), as they may cause temporary or medically reversible adverse health consequences.
Plain-English summary
US Compounding Inc is recalling 1,096 vials of Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vials. The product is compounded by US Compounding Pharmacy in Conway, Arkansas, and was distributed nationwide. The recall involves specific lot numbers with expiration dates in 2015.
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. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected vials immediately. The product is prescription-only and not for intravenous use. Those who have used the product should consult their healthcare provider if they have concerns about potential sterility issues.
The recalled product
- Product
- Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3239-01
- Manufacturer
- US Compounding Inc
- Affected units
- 1,096
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 Numbers: 20150608@1 BUD: 10/5/2015
- 20152707@4 BUD: 9/23/2015
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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