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West-ward Pharmaceutical Corp.

West-ward Pharmaceutical Corp. Recalls

All product recalls associated with West-ward Pharmaceutical 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 21–35 of 35 recalls

Ethambutol Tablets (West-ward) – Subpotent Medication (2013)

Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.

Class IIModerate

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

Ciprofloxacin Tablets (West-ward) – Foreign Substance (2013)

Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.

Class IIModerate

FDAFeb 6, 2013AR, GA• West-ward Pharmaceutical Corp.

Glycopyrrolate Tablets (West-ward) – Subpotent Drug (2013)

Subpotent Drug

Class IIILow

Page 2 of 2Next

FDAJan 7, 2013OH• West-ward Pharmaceutical Corp.

Belladonna Alkaloids (West-ward) – Foreign Substance (2013)

Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.

Class IIModerate

FDAJan 7, 2013Nationwide• West-ward Pharmaceutical Corp.

Propylthiouracil Tablets (West-ward) - steel corrosion spots (2012)

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.

Class IIModerate

FDADec 7, 2012Nationwide• West-ward Pharmaceutical Corp.

Carisoprodol Tablets (West-ward) - black tablet spots (2012)

Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.

Class IIModerate

FDADec 7, 2012Nationwide• West-ward Pharmaceutical Corp.

Lisinopril Tablets (West-ward Pharmaceutical) – Foreign Substance (2012)

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.

Class IIModerate

FDADec 7, 2012Nationwide• West-ward Pharmaceutical Corp.

PredniSONE Tablets (West-ward) - black specks (2012)

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.

Class IIModerate

FDADec 5, 2012Nationwide• West-ward Pharmaceutical Corp.

PredniSONE Tablets (West-ward) - gray tablet defects (2012)

Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.

Class IIModerate

FDADec 5, 2012Nationwide• West-ward Pharmaceutical Corp.

Isoniazid Tablets (West-ward) - dissolution specification (2012)

Failed Dissolution Specifications; 36 month stability timepoint

Class IIModerate

FDADec 4, 2012GA• West-ward Pharmaceutical Corp.

Lisinopril Hydrochlorothiazide (West-ward) - steel particulates (2012)

Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.

Class IIModerate

FDANov 30, 2012Nationwide• West-ward Pharmaceutical Corp.

Ethambutol Tablets (West-ward) - tablet discoloration (2012)

Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.

Class IIModerate

FDANov 30, 2012GA• West-ward Pharmaceutical Corp.

Carisoprodol Tablets (West-ward) - DEA schedule change (2012)

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.

Class IIILow

FDANov 30, 2012Nationwide• West-ward Pharmaceutical Corp.

Fosphenytoin Sodium Injection 100mg (West-ward) – Particulate Matter (2012)

Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.

Class IIModerate

FDAApr 13, 2012Nationwide• West-ward Pharmaceutical Corp.

Fosphenytoin Sodium Injection 500mg (West-ward) – Particulate Matter (2012)

Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.

Class IIModerate

FDAApr 13, 2012Nationwide• West-ward Pharmaceutical Corp.