October 2013 FDA Recall Alprazolam by Actavis Elizabeth Llc
D-018-2014 - Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
This Class II drug recall was voluntarily initiated by Actavis Elizabeth Llc on October 9, 2013 for the product Alprazolam. The FDA reported the reason for recall as failed tablet/capsule specifications; partial tablet erosion resulting in tablet weights below specification in some tablets. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-018-2014
Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets
10-09-2013
12-04-2013
756 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Actavis Elizabeth LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
11-03-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Only, MFG. BY ACTAVIS ELIZABETH LLC., Elizabeth, NJ, NDC 0228-4025-11
Batch or Lot Expiration Information
Lot# 59380831, Exp. May 2014
