Hyoscyamine sulfate .125 mg/mL

Aidapak Services, LLC

Labeling: Label Mixup; HYOSCYAMINE SULFATE ER Tablet, 0.375 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: W003575, EXP: 6/24/2014.

Physicians Total Care, Inc.

Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Virtus Pharmaceuticals, Llc

Chemical Contamination: Bottles may contain broken dessicants

Viatris Inc

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Vilvet Pharmaceuticals Inc.

cGMP deviations

West-ward Pharmaceutical Corp.

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

Aidapak Services, LLC

Labeling: Label Mixup: HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg may have potentially been mislabeled as the following drug: FLUoxetine HCl, Capsule, 10 mg, NDC 16714035103, Pedigree: W003613, EXP: 6/25/2014.

VIRTUS PHARMACEUTICALS OPCO II L

Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.

Burel Pharmaceuticals Inc

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures