August 2017 FDA Recall Drug by Vital Rx, Inc. Dba Atlantic Pharmacy And Compounding
D-0148-2018 - Lack of Assurance of Sterility .
This Class II drug recall was voluntarily initiated by Vital Rx, Inc. Dba Atlantic Pharmacy And Compounding on August 17, 2017 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-0148-2018
Lack of Assurance of Sterility .
08-17-2017
12-27-2017
61 Products
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.
Vital Rx, Inc. dba Atlantic Pharmacy and Compounding
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
All Sterile Products within expiry
Batch or Lot Expiration Information
Lot# Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products
