Multi-event April 2022 FDA Recall Drug by Sca Pharmaceuticals

This Multi-event Class II drug recall was voluntarily initiated by Sca Pharmaceuticals on April 25, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0829-2022 TERMINATED D-0830-2022 TERMINATED D-0831-2022 TERMINATED

Recall Number: D-0829-2022

Reason for Recall
CGMP Deviations
Initiated
04-25-2022
Reported
05-11-2022
Quantity
120 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90080
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-09-2022
Product Description About Product Description
Full technical description of the product.
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40

Batch or Lot Expiration Information

Lot# : 1222035815, Exp. Date 10-Jul-22

Recall Number: D-0830-2022

Reason for Recall
CGMP Deviations
Initiated
04-25-2022
Reported
05-11-2022
Quantity
424 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90080
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-09-2022
Product Description About Product Description
Full technical description of the product.
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32

Batch or Lot Expiration Information

Lot# : 1222035837, Exp. Date 22-Jul-22
Lot# : 1222035804, Exp. Date 25-Jul-22

Recall Number: D-0831-2022

Reason for Recall
CGMP Deviations
Initiated
04-25-2022
Reported
05-11-2022
Quantity
30 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90080
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-09-2022
Product Description About Product Description
Full technical description of the product.
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44

Batch or Lot Expiration Information

Lot# : 1222035839, Exp. Date 09-Aug-22