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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
See all 10 products in this recall →Related recalls
Same manufacturer · SCA Pharmaceuticals, LLC
See all →- HighPhenylephrine HCl Injections Recalled Nationwide for Sterility Assurance Issues
FDA (Drugs) · 2024-04-03
- HighInjectable midazolam HCl recalled due to sterility assurance failure
FDA (Drugs) · 2024-04-03
- HighFentanyl and Bupivacaine Epidural Injection Recalled for Sterility Assurance Issue
FDA (Drugs) · 2024-04-03
- HighHydromorphone Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-04-03
- HighHYDROmorphone HCl 6 mg Injectable Syringes Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2024-04-03
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighFDA Recalls SCA Fentanyl-Bupivacaine Epidural Injection Cassettes Lacking Sterility Assurance
FDA (Drugs) · 2024-04-03
- HighFDA Recalls Fentanyl-Bupivacaine Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2024-04-03
- SevereSCA Pharmaceuticals Recalls Fentanyl and Ropivacaine Syringes Due to Sterility Concerns
FDA (Drugs) · 2021-01-13
- HighFentanyl and Bupivacaine Epidural Injection Recalled for Sterility Assurance Issue
FDA (Drugs) · 2024-04-03
- SevereSCA Pharmaceuticals Recalls Fentanyl Citrate Injection Bags Due to Sterility Concerns
FDA (Drugs) · 2017-08-02
- SevereSCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns
FDA (Drugs) · 2021-01-13