April 2018 FDA Recall Drug by Aidarex Pharmaceuticals Llc
D-0810-2018 - Presence of Foreign Tablets/Capsules

This Class III drug recall was voluntarily initiated by Aidarex Pharmaceuticals Llc on April 10, 2018 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed in Product was distributed to Florida and the recall is currently terminated.

Recall Number: D-0810-2018

Reason for Recall
Presence of Foreign Tablets/Capsules
Initiated
04-10-2018
Reported
05-23-2018
Quantity
450 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79835
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.
Aidarex 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to Florida
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2019
Product Description About Product Description
Full technical description of the product.
Ferrous Sulfate 325 MG tablet; NDC 33261-0715-00

Batch or Lot Expiration Information

Batch# NDC 33261-0715-00 Batch ID: 57909-1, exp. date 04/30/2019 57909-2, exp. date 06/30/2019