July 2023 FDA Recall Drug by Sca Pharmaceuticals
D-0945-2023 - cGMP deviations
This Class II drug recall was voluntarily initiated by Sca Pharmaceuticals on July 20, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in KY and NJ and the recall is currently terminated.
Recall Number: D-0945-2023
cGMP deviations: due to shipment of rejected units.
07-20-2023
08-02-2023
183 bags
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SCA Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
KY and NJ
09-21-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 1223047134, Use By: 09/21/2023
