April 2019 FDA Recall Drug by Us Worldmeds Llc
D-1275-2019 - Presence of Precipitate
This Class II drug recall was voluntarily initiated by Us Worldmeds Llc on April 25, 2019 for the product Drug. The FDA reported the reason for recall as presence of precipitate. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1275-2019
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
04-25-2019
05-08-2019
6456 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.
US Worldmeds 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.
Nationwide in the USA
09-17-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67
Batch or Lot Expiration Information
Lot# Lot: 17REV01, Exp. 12/2019
