August 2019 FDA Recall Drug by Atlas Pharmaceuticals, Llc
D-0144-2020 - Labeling

This Class II drug recall was voluntarily initiated by Atlas Pharmaceuticals, Llc on August 28, 2019 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Healthcare facilities/clinics in AZ and CO and the recall is currently terminated.

Recall Number: D-0144-2020

Reason for Recall
Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
Initiated
08-28-2019
Reported
10-23-2019
Quantity
1646 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83710
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.
Atlas 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.
Healthcare facilities/clinics in AZ and CO
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-03-2020
Product Description About Product Description
Full technical description of the product.
Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy, Suite 107, Phoenix, AZ 85085, NDC 71591-500-50.

Batch or Lot Expiration Information

Lot# : S-60162, BUD 10/12/2019; S-60176, BUD 11/2/2019; S-60187, BUD 11/11/2019; S-60189, BUD 11/16/2019; S-60190, BUD 11/16/2019; S-60222, BUD 01/20/2020