FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
Reported: August 2, 2023 Initiated: July 20, 2023 #D-0945-2023
Product Description
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
Reason for Recall
cGMP deviations: due to shipment of rejected units.
Details
- Recalling Firm
- SCA Pharmaceuticals
- Units Affected
- 183 bags
- Distribution
- KY and NJ
- Location
- Windsor, CT
Frequently Asked Questions
What product was recalled? ▼
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40. Recalled by SCA Pharmaceuticals. Units affected: 183 bags.
Why was this product recalled? ▼
cGMP deviations: due to shipment of rejected units.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 2, 2023. Severity: Moderate. Recall number: D-0945-2023.
Related Recalls
FDA Drug Moderate
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: U…
Unichem Pharmaceuticals USA Inc. · 2026-02-11
FDA Drug Critical
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San…
Green Lumber Holdings, LLC · 2026-02-11
FDA Drug Moderate
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500…
Granules Pharmaceuticals Inc. · 2026-02-11
FDA Drug Critical
Diclofenac Sodium, Topical Gel, 3%, 100 g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1…
SUN PHARMACEUTICAL INDUSTRIES INC · 2026-02-11
FDA Drug Critical
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
HANDELNINE GLOBAL LLC · 2026-02-11