Home / Recalls / Actavis Laboratories, FL, Inc. / D-1616-2014

D-1616-2014 Class II Terminated

Recalled by Actavis Laboratories, FL, Inc. — Davie, FL

Recall Details

Product Type
Drugs
Report Date
October 8, 2014
Initiation Date
April 24, 2014
Termination Date
December 23, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36,538 bottles

Product Description

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.

Reason for Recall

Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: 605956A, 605958A, Exp. 9/30/2014; 644678M, Exp. 10/31/2014; 661841A, Exp. 11/30/2014; 717469A, Exp 2/28/2015

Other recalls by Actavis Laboratories, FL, Inc.

  • D-0118-2017 Class III — Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arro (August 30, 2016)
  • D-0014-2016 Class II — Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx o (September 25, 2015)
  • D-1285-2015 Class III — Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by (June 23, 2015)
  • D-0488-2015 Class III — Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 (March 26, 2015)
  • D-0258-2015 Class II — Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-coun (September 26, 2014)
  • D-1617-2014 Class II — Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-coun (April 24, 2014)