September 2017 FDA Recall Drug by Aidarex Pharmaceuticals Llc
D-1162-2017 - Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test

This Class III drug recall was voluntarily initiated by Aidarex Pharmaceuticals Llc on September 5, 2017 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specification; out-of-specification results for individual unknown impurities at the 30 month room temperature retained sample stability test. The product was distributed in Distributed to the state of CA and NV. and the recall is currently terminated.

Recall Number: D-1162-2017

Reason for Recall
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Initiated
09-05-2017
Reported
09-20-2017
Quantity
35 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78067
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.
Distributed to the state of CA and NV.
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.
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30

Batch or Lot Expiration Information

Batch# Batch 47262-2, 47262-3, exp 8/31/2017; 47262-4, exp 12/30/17, 47262-5, 47262-6, 47262-7, exp 12/31/17