Home / Recalls / Sandoz Incorporated / D-597-2013

D-597-2013 Class II Terminated

Recalled by Sandoz Incorporated — Broomfield, CO

Recall Details

Product Type
Drugs
Report Date
June 19, 2013
Initiation Date
May 30, 2013
Termination Date
July 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
297,200 vials

Product Description

Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box)

Reason for Recall

Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.

Distribution Pattern

Nationwide and Puerto Rico.

Code Information

Lot #: DB2208, Exp 01/16

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-832-2013 Class I — Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Sing (May 20, 2013)