Home / Recalls / West-Ward Pharmaceutical Corp. / D-0172-2015

D-0172-2015 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
November 5, 2014
Initiation Date
October 2, 2014
Termination Date
August 3, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,596 HDPE bottles

Product Description

VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta, GA 30065-1509 Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 61748-011-01

Reason for Recall

Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.

Distribution Pattern

GA

Code Information

Lot #68975A, #68976; Exp. 07/15

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-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-66447-001 Class II — Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose (September 23, 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-883-2013 Class II — Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) a (July 30, 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-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)