Home / Recalls / Actavis Laboratories, FL, Inc. / D-0014-2016

D-0014-2016 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
October 21, 2015
Initiation Date
September 25, 2015
Termination Date
April 10, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,284 bottles

Product Description

Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.

Reason for Recall

Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot: 1037736A, Exp 03/18

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-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-1616-2014 Class II — Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-coun (April 24, 2014)
  • D-1617-2014 Class II — Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-coun (April 24, 2014)