Diclofenac Sodium and Misoprostol 75 mg / 200 ug tablet, delayed release

Where the pills inside were made

This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Actavis Pharma, Inc. names for other drugs.

Repackaging site

• Blenheim Pharmacal, Inc., North Blenheim, New York, United States · relabels it

Recalls

• Sep 26, 2014 · Class II · Actavis Laboratories, FL, Inc.
  Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
  Lots: Lot # 694320A, Expiry: 02/28/2015.
• Apr 24, 2014 · Class II · Actavis Laboratories, FL, Inc.
  Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
  Lots: Lot #: 605956A, 605958A, Exp. 9/30/2014; 644678M, Exp. 10/31/2014; 661841A, Exp. 11/30/2014; 717469A, Exp 2/28/2015
• Dec 20, 2013 · Class II · Watson Laboratories, Inc.-(Actavis) - Florida
  Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
  Lots: Lot# 605957A, Exp 09/14
• Mar 22, 2013 · Class II · Actavis Inc
  Failed Tablet/Capsule Specifications: Broken tablets
  Lots: Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015
• Mar 22, 2013 · Class II · Watson Laboratories, Inc.-(Actavis) - Florida
  Failed Tablet/Capsule Specifications: Broken tablets
  Lots: Lot 635098A, Exp 10/14

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Diclofenac and Misoprostol: every company that makes it

Form

tablet, delayed release

Strength

75 mg / 200 ug

Approval

ANDA ANDA201089

On the market since

Oct 7, 2015

Package NDCs

10544-949-14

Official label

DailyMed (National Library of Medicine), updated Oct 8, 2015

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