October 2017 FDA Recall Drug by Teva Pharmaceuticals Usa
D-0069-2018 - Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on October 25, 2017 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0069-2018

Reason for Recall
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Initiated
10-25-2017
Reported
11-08-2017
Quantity
140,993 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78364
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.
Teva Pharmaceuticals USA
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 the USA and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-02-2018
Product Description About Product Description
Full technical description of the product.
Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# Lot Numbers: a) 1089376A, 1089382A, 1095210M, 1117768M, 1117769A, Exp. 11/17; 1128452A, 1128453A, 1137658A, 1154207A, 1156087A, Exp. 03/18; b) 1089379A, 1091533M, 1125206A, Exp. 11/17; 1128456A, 1147665A, 1154208A, 1156088A, Exp. 03/18.