fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40
Reported: November 8, 2017 Initiated: October 19, 2017 #D-0062-2018
Product Description
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40
Reason for Recall
Lack Of Assurance Of Sterility.
Details
- Recalling Firm
- SCA Pharmaceuticals, LLC
- Units Affected
- 116 bags
- Distribution
- Nationwide in the United States
- Location
- Little Rock, AR
Frequently Asked Questions
What product was recalled? ▼
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40. Recalled by SCA Pharmaceuticals, LLC. Units affected: 116 bags.
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-0062-2018.
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