US Compounding Recalls Fentanyl Syringes Due to Sterility Assurance Concerns
US Compounding Inc is recalling 711 fentanyl syringes 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 involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the text, the risk of sterility failure in injectable drugs is significant.
Plain-English summary
US Compounding Inc is recalling 711 single-use syringes of Fentanyl PF 50 mL (25 mcg/mL) for IV, IM, or SC injection. The product was compounded by US Compounding Pharmacy in Conway, Arkansas, and distributed nationwide.
The recall is 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 dates. The specific lot numbers affected are 20150604@20 (BUD: 10/3/2015), 20152306@20 (BUD: 12/20/2015), and 20152403@28 (BUD: 9/20/2015).
The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0002-50
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 711
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 (3)
- Lot Numbers: 20150604@20 BUD: 10/3/2015
- 20152306@20 BUD: 12/20/2015
- 20152403@28 BUD: 9/20/2015
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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