October 2019 FDA Recall Drug by Ingenus Pharmaceuticals Llc
D-0146-2020 - Crystallization
This Class II drug recall was voluntarily initiated by Ingenus Pharmaceuticals Llc on October 9, 2019 for the product Drug. The FDA reported the reason for recall as crystallization. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0146-2020
Crystallization: Presence of particulate matter identified as API crystallization
10-09-2019
10-23-2019
16485 vials
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.
Ingenus Pharmaceuticals Llc
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.
U.S.A. Nationwide
12-01-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
Batch or Lot Expiration Information
Lot# : 18048, 18049 Exp. 04/2020; 18050 Exp 05/2020; 19036 Exp 12/2020
