June 2016 FDA Recall Drug by Aidarex Pharmaceuticals Llc
D-0974-2016 - CGMP Deviations

This Class III drug recall was voluntarily initiated by Aidarex Pharmaceuticals Llc on June 1, 2016 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in IN, GA and the recall is currently terminated.

Recall Number: D-0974-2016

Reason for Recall
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Initiated
06-01-2016
Reported
06-15-2016
Quantity
10

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74316
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.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
IN, GA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-14-2016
Product Description About Product Description
Full technical description of the product.
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01

Batch or Lot Expiration Information

Lot# : 47312-1, Exp 01/2018