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West-Ward Pharmaceutical Recalls
30 recalls on record · August 8, 2012 to October 12, 2016 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 12, 2016DrugsFDA
West-Ward Pharmaceutical recalls PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 077
Hazard: Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
June 24, 2015DrugsFDA
West-Ward Pharmaceutical Corp. recalls 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
Hazard: Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
April 1, 2015DrugsFDA
West-Ward Pharmaceutical Corporation recalls Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or I
Hazard: Failed Impurities/Degradation Specifications; 12 month stability testing.
November 5, 2014DrugsFDA
West-Ward Pharmaceutical Corp. recalls VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for Versa
Hazard: Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
July 9, 2014DrugsFDA
West-Ward Pharmaceutical Corp. recalls Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC
Hazard: Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
December 25, 2013DrugsFDA
West-Ward Pharmaceutical Corp. recalls Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. M
Hazard: Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
November 13, 2013DrugsFDA
West-Ward Pharmaceutical Corp. recalls Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured
Hazard: 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.
November 13, 2013DrugsFDA
West-Ward Pharmaceutical Corp. recalls Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured b
Hazard: 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.
August 21, 2013DrugsFDA
West-Ward Pharmaceutical Corp. recalls Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bot
Hazard: Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
August 14, 2013DrugsFDA
West-Ward Pharmaceutical Corp. recalls Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles
Hazard: Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.
August 14, 2013DrugsFDA
West-Ward Pharmaceutical Corp. recalls VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorpora
Hazard: 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.
July 31, 2013DrugsFDA
West-Ward Pharmaceutical Corp. recalls West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured
Hazard: Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
July 31, 2013DrugsFDA
West-Ward Pharmaceutical Corp. recalls West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle
Hazard: Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
July 17, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Scien
Hazard: Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
May 8, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmace
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.
April 10, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated,
Hazard: Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
April 3, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntow
Hazard: Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
March 27, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Co
Hazard: Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.
March 13, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09,
Hazard: Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.
March 6, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd
Hazard: Failed Dissolution Specifications; 36 month stability timepoint
March 6, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 m
Hazard: Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
February 20, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eat
Hazard: Subpotent Drug
February 13, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tabl
Hazard: Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
February 13, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets pe
Hazard: Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
January 30, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per
Hazard: Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.
January 30, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01)
Hazard: Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
January 30, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count t
Hazard: Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.
January 30, 2013DrugsFDA
West-ward Pharmaceutical Corp. recalls Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per
Hazard: Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.
August 8, 2012DrugsFDA
West-ward Pharmaceutical Corp. recalls Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count
Hazard: Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
August 8, 2012DrugsFDA
West-ward Pharmaceutical Corp. recalls Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x
Hazard: Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.