January 2018 FDA Recall Drug by Advanced Pharma Inc.
D-0575-2018 - Subpotent

This Class I drug recall was voluntarily initiated by Advanced Pharma Inc. on January 5, 2018 for the product Drug. The FDA reported the reason for recall as subpotent. The product was distributed in Texas and the recall is currently terminated.

Recall Number: D-0575-2018

Reason for Recall
Subpotent
Initiated
01-05-2018
Reported
01-31-2018
Quantity
25 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78889
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Advanced Pharma 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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-05-2019
Product Description About Product Description
Full technical description of the product.
MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10

Batch or Lot Expiration Information

Lot# Lot: 12/22/17 1422 108-90710P UD: 3/22/2018