SCA Pharmaceuticals Recalls Fentanyl and Ropivacaine CADD Cassettes
SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine CADD cassettes due to a lack of assurance of sterility.
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, and the hazard of a lack of assurance of sterility in an injectable drug poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1% in 0.9% Sodium Chloride single dose CADD Cassettes. The recall involves 20 bags inside rigid translucent plastic cases (CADD) with Lot 20170815@26 and a Beyond Use Date of 11/13/2017. The product is distributed nationwide in the United States.
The recall was initiated due to a lack of assurance of sterility. This means the manufacturer cannot guarantee that the product is free from microbial contamination, which poses a risk of infection to patients using the device.
Healthcare providers and patients should stop using the affected cassettes immediately. Consumers should contact their healthcare provider or the recalling firm for further instructions on how to dispose of or replace the product.
The recalled product
- Product
- fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable
- Affected units
- 20
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: 20170815@26 BUD: 11/13/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by SCA Pharmaceuticals, LLC 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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