December 2020 FDA Recall Drug by Us Compounding Inc
D-0223-2021 - Labeling

This Class III drug recall was voluntarily initiated by Us Compounding Inc on December 16, 2020 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0223-2021

Reason for Recall
Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
Initiated
12-16-2020
Reported
01-20-2021
Quantity
1534 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86997
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
US Compounding Inc
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.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-05-2021
Product Description About Product Description
Full technical description of the product.
Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032

Batch or Lot Expiration Information

Lot# : 20202010@6 BUD: 02/17/2021