West-Ward Pharmaceutical

Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.

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

Failed Impurities/Degradation Specifications; 12 month stability testing.

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

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

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

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.

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.

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

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

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.

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

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

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

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.

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

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

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.

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

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

Failed Dissolution Specifications; 36 month stability timepoint

Subpotent Drug

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

Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.

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.

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.

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.

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

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

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