Prescription Drugs

Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP.

Presence of Particulate Matter

Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.

Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.

Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.

Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value

Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.

Impurities/Degradation Products: exceeded specification at 3 month stability testing

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.

CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.

Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.

Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point