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D-66447-001 Class II Terminated

Recalled by West-Ward Pharmaceutical Corp. — Eatontown, NJ

Recall Details

Product Type
Drugs
Report Date
November 13, 2013
Initiation Date
September 23, 2013
Termination Date
April 5, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9020 vials

Product Description

Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9702-01.

Reason for Recall

Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.

Distribution Pattern

Nationwide

Code Information

Lot #: AC0020, Exp 03/14; AC0023, AC0025, Exp 08/14

Other recalls by West-Ward Pharmaceutical Corp.

  • D-0008-2017 Class II — PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward P (October 3, 2016)
  • D-1139-2015 Class III — Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, (May 13, 2015)
  • D-0172-2015 Class II — VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count (October 2, 2014)
  • D-1414-2014 Class II — Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0 (May 20, 2014)
  • D-367-2014 Class II — Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pha (November 7, 2013)
  • D-66447-002 Class II — Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose (September 23, 2013)
  • D-853-2013 Class II — Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC (July 30, 2013)
  • D-883-2013 Class II — Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) a (July 30, 2013)
  • D-839-2013 Class II — VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets (June 4, 2013)
  • D-824-2013 Class II — West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (May 16, 2013)