June 2015 FDA Recall Drug by Actavis Laboratories, Fl, Inc.
D-1285-2015 - Tablets/Capsules Imprinted with Wrong ID

This Class III drug recall was voluntarily initiated by Actavis Laboratories, Fl, Inc. on June 23, 2015 for the product Drug. The FDA reported the reason for recall as tablets/capsules imprinted with wrong id. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1285-2015

Reason for Recall
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
Initiated
06-23-2015
Reported
08-12-2015
Quantity
11,445 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71755
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.
Actavis Laboratories, FL, Inc.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-30-2016
Product Description About Product Description
Full technical description of the product.
Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by Actavis Pharma, Inc. Parsippany, NJ 07054 USA. NDC: 0591-2464-01.

Batch or Lot Expiration Information

Lot# 982021M, Expiry: DEC. 2016