Drug Enforcement D-817-2013

Failed Tablet/Capsule Specifications: Broken tablets

Status

Terminated

Classification

Class II

Report Date

July 31, 2013

Termination Date

September 25, 2014

Product Information

Product description
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
Product quantity
392,400 tablets
Reason for recall
Failed Tablet/Capsule Specifications: Broken tablets
Recall initiation reason
—
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Watson Laboratories, Inc.-(Actavis) - Florida
Address
4955 Orange Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-817-2013
Event ID
65541
Recall initiation date
March 22, 2013
Center classification date
July 23, 2013
Code info
Lot 635098A, Exp 10/14
More code info
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