August 2019 FDA Recall Drug by Sca Pharmaceuticals, Llc
D-1843-2019 - Lack of Assurance of Sterility.

This Class II drug recall was voluntarily initiated by Sca Pharmaceuticals, Llc on August 16, 2019 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1843-2019

Reason for Recall
Lack of Assurance of Sterility.
Initiated
08-16-2019
Reported
08-28-2019
Quantity
922 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83580
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, LLC
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.
Nationwide in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-15-2019
Product Description About Product Description
Full technical description of the product.
Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.

Batch or Lot Expiration Information

Lot# : 1219010961, Exp. 10/24/2019