D-1060-2014 Class II Terminated

Recalled by Actavis Inc — Parsippany, NJ

FDA drug recall D-1060-2014 was initiated by Actavis Inc on Mar 22, 2013 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specifications: Broken tablets The recall status is terminated (terminated Feb 26, 2015). Affected quantity: 6,540 bottles.

Recall details

Product Type
Drugs
Report Date
Feb 12, 2014
Initiation Date
Mar 22, 2013
Termination Date
Feb 26, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,540 bottles

Product description

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)

Reason for recall

Failed Tablet/Capsule Specifications: Broken tablets

Distribution pattern

Nationwide

Code information

Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1060-2014
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for D-1060-2014. Report a data issue: hello@regdatalab.com.