Skip to main content

West-Ward Pharmaceutical Corp.

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20122
201323
20142
20151
Download CSV

FDA Recall Terminated Historical recordClass III

Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.

by West-Ward Pharmaceutical Corp.

Reason
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Published
June 24, 2015
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

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

by West-Ward Pharmaceutical Corp.

Reason
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Published
November 5, 2014
Distribution
GA

View recall →

FDA Recall Terminated Historical recordClass II

Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

by West-Ward Pharmaceutical Corp.

Reason
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Published
July 9, 2014
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.

by West-Ward Pharmaceutical Corp.

Reason
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Published
December 25, 2013
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 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 0143-9701-01.

by West-Ward Pharmaceutical Corp.

Reason
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.
Published
November 13, 2013
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

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.

by West-Ward Pharmaceutical Corp.

Reason
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.
Published
November 13, 2013
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.

by West-Ward Pharmaceutical Corp.

Reason
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
Published
August 21, 2013
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.

by West-Ward Pharmaceutical Corp.

Reason
Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.
Published
August 14, 2013
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06,

by West-Ward Pharmaceutical Corp.

Reason
Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.
Published
August 14, 2013
Distribution
GA

View recall →

FDA Recall Terminated Historical recordClass II

West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724

by West-Ward Pharmaceutical Corp.

Reason
Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
Published
July 31, 2013
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724

by West-Ward Pharmaceutical Corp.

Reason
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
Published
July 31, 2013
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

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

by West-Ward Pharmaceutical Corp.

Reason
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Published
July 17, 2013
Distribution
Nationwide

View recall →

This page lists recalls that name West-Ward Pharmaceutical Corp. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.