Drug Enforcement D-0945-2023

cGMP deviations: due to shipment of rejected units.

Status

Terminated

Classification

Class II

Report Date

August 2, 2023

Termination Date

September 21, 2023

Product Information

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
Product quantity
183 bags
Reason for recall
cGMP deviations: due to shipment of rejected units.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
KY and NJ

Location & Firm

Recalling firm
SCA Pharmaceuticals
Address
755 Rainbow Rd Ste B, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0945-2023
Event ID
92737
Recall initiation date
July 20, 2023
Center classification date
July 26, 2023
Code info
Lot # 1223047134, Use By: 09/21/2023
More code info
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