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West-Ward Pharmaceuticals Corp.

West-Ward Pharmaceuticals Corp. Recalls

All product recalls associated with West-Ward Pharmaceuticals Corp..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Nov 2017

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 35 recalls

Dexamethasone Sodium Phosphate 20 mg/5 mL (West-Ward) – impurity concerns (2017)

Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).

Class IIILow

FDANov 6, 2017Nationwide• West-Ward Pharmaceuticals Corp.

Dexamethasone Sodium Phosphate 4 mg/mL (West-Ward) – impurity concerns (2017)

Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).

Class IIILow

FDANov 6, 2017Nationwide• West-Ward Pharmaceuticals Corp.

Sodium Ferric Gluconate (West-Ward) – Subpotent Drug (2016)

Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.

Page 1 of 2Next

Class IIILow

FDANov 17, 2016Nationwide• West-Ward Pharmaceuticals Corp.

Amoxicillin Suspension (West-Ward) – Labeling Error (2016)

Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.

Class IIILow

FDANov 4, 2016Nationwide• West-Ward Pharmaceuticals Corp.

Phenobarbital Tablets (West-Ward) – Dissolution Failure (2016)

Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point

Class IIModerate

FDAOct 3, 2016Nationwide• West-Ward Pharmaceuticals Corp.

Amoxicillin Suspension (West-Ward) – Missing Label Panel (2016)

Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.

Class IIILow

FDAAug 18, 2016Nationwide• West-Ward Pharmaceuticals Corp.

Fentanyl Citrate Injection (West-Ward) – Impurity Specification Failure (2015)

Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).

Class IIILow

FDAMay 13, 2015Nationwide• West-Ward Pharmaceutical Corp.

Fentanyl Citrate Injection (West-Ward) – Degradation Specs (2015)

Failed Impurities/Degradation Specifications; 12 month stability testing.

Class IIILow

FDAFeb 16, 2015Nationwide• West-Ward Pharmaceutical Corporation

Ethambutol Hydrochloride Tablets (West-Ward) – Subpotency (2014)

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

Class IIModerate

FDAOct 2, 2014GA• West-Ward Pharmaceutical Corp.

Isoniazid Tablets (West-Ward) – dissolution failure (2014)

Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.

Class IIModerate

FDAMay 20, 2014Nationwide• West-Ward Pharmaceutical Corp.

Carisoprodol Tablets (West-Ward) – Foreign Substance (2013)

Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing

Class IIModerate

FDANov 7, 2013Nationwide• West-Ward Pharmaceutical Corp.

Irinotecan Injection (West-Ward) – Superpotent Drug Calculation (2013)

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.

Class IIModerate

FDASep 23, 2013Nationwide• West-Ward Pharmaceutical Corp.

Irinotecan Injection (West-Ward) – Superpotent Drug Calculation (2013)

Class IIModerate

FDASep 23, 2013Nationwide• West-Ward Pharmaceutical Corp.

Lisinopril Tablets (West-Ward) – Impurity Specification (2013)

Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.

Class IIModerate

FDAJul 30, 2013Nationwide• West-Ward Pharmaceutical Corp.

Belladonna Alkaloids Tablets (West-Ward) – Foreign Substance (2013)

Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets

Class IIModerate

FDAJul 30, 2013Nationwide• West-Ward Pharmaceutical Corp.

Ethambutol Tablets (West-Ward) – Surface Defect (2013)

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.

Class IIModerate

FDAJun 4, 2013GA• West-Ward Pharmaceutical Corp.

Belladonna Alkaloids Tablets (West-Ward) – cross contamination (2013)

Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.

Class IIModerate

FDAMay 16, 2013Nationwide• West-Ward Pharmaceutical Corp.

Belladonna Alkaloids Tablets (West-Ward) – foreign substance (2013)

Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.

Class IIModerate

FDAMay 16, 2013Nationwide• West-Ward Pharmaceutical Corp.

Nicardipine Hydrochloride Injection (West-ward) – Impurity Specification (2013)

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

Class IIILow

FDAMay 13, 2013Nationwide• West-ward Pharmaceutical Corp.

Donnatal Extentabs (West-ward) – Incorrect Labeling (2013)

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.

Class IIModerate

FDAMar 18, 2013Nationwide• West-ward Pharmaceutical Corp.