May 2014 FDA Recall Drug by Aidarex Pharmaceuticals Llc
D-0042-2015 - Presence of Foreign Tablets/Capsules

This Class II drug recall was voluntarily initiated by Aidarex Pharmaceuticals Llc on May 22, 2014 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0042-2015

Reason for Recall
Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg
Initiated
05-22-2014
Reported
10-29-2014
Quantity
531 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68375
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.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2014
Product Description About Product Description
Full technical description of the product.
Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India

Batch or Lot Expiration Information

Lot# Lot 39661-3 Exp. 07/15