Home / Recalls / West-ward Pharmaceutical Corp. / D-691-2013

D-691-2013 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
July 17, 2013
Initiation Date
May 13, 2013
Termination Date
March 17, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials

Product Description

Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10

Reason for Recall

Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)

Distribution Pattern

Nationwide

Code Information

Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014

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-66447-001 Class II — Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 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)