Home / Recalls / Sandoz Incorporated / D-1678-2012

D-1678-2012 Class III Terminated

Recalled by Sandoz Incorporated — Broomfield, CO

Recall Details

Product Type
Drugs
Report Date
September 26, 2012
Initiation Date
September 12, 2012
Termination Date
April 10, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
41,761bottles.

Product Description

Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92

Reason for Recall

Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.

Distribution Pattern

Nationwide

Code Information

Lot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12

Other recalls by Sandoz Incorporated

  • D-0631-2018 Class III — Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles (April 6, 2018)
  • D-0943-2017 Class III — Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781- (June 16, 2017)
  • D-0236-2017 Class II — Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured (December 22, 2016)
  • D-0291-2015 Class III — Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz (December 5, 2014)
  • D-1509-2014 Class II — Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, (July 25, 2014)
  • D-383-2014 Class II — Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in (October 22, 2013)
  • D-66373-001 Class III — Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle (September 25, 2013)
  • D-854-2013 Class III — Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, (August 7, 2013)
  • D-805-2013 Class II — Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X2 (June 21, 2013)
  • D-597-2013 Class II — Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, singl (May 30, 2013)