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
Reported: November 8, 2017 Initiated: October 19, 2017 #D-0063-2018
Product Description
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
Reason for Recall
Lack Of Assurance Of Sterility.
Details
- Recalling Firm
- SCA Pharmaceuticals, LLC
- Units Affected
- 20 bags inside rigid translucent plastic cases (CADD)
- Distribution
- Nationwide in the United States
- Location
- Little Rock, AR
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SCA Pharmaceuticals, LLC. Units affected: 20 bags inside rigid translucent plastic cases (CADD).
Why was this product recalled? ▼
Lack Of Assurance Of Sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 8, 2017. Severity: Moderate. Recall number: D-0063-2018.
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