Home / Recalls / Teva North America / D-1451-2016

D-1451-2016 Class III Terminated

Recalled by Teva North America — Horsham, PA

FDA drug recall D-1451-2016 was initiated by Teva North America on May 31, 2016 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: High out of specification results for Impurity D. The recall status is terminated (terminated May 8, 2017). Affected quantity: 2,506 vials.

Recall Details

Product Type
Drugs
Report Date
August 3, 2016
Initiation Date
May 31, 2016
Termination Date
May 8, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,506 vials

Product Description

mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.

Reason for Recall

Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.

Distribution Pattern

Nationwide

Code Information

Lot # 31318659B, Exp 02/17

Other recalls by Teva North America

  • D-0005-2017 Class III — Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Bli (August 5, 2016)
  • D-1453-2016 Class III — Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per (July 15, 2016)
  • D-1470-2016 Class II — Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufa (June 24, 2016)
  • D-1455-2016 Class II — Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Can (June 22, 2016)
  • D-1494-2016 Class II — ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, (June 17, 2016)
  • D-1495-2016 Class II — Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHAR (June 17, 2016)
  • D-1496-2016 Class II — Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenou (June 17, 2016)
  • D-1497-2016 Class II — Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungar (June 17, 2016)
  • D-1449-2016 Class III — Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Ma (May 18, 2016)
  • D-0868-2016 Class II — Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), (April 27, 2016)

FDA data resources