Class II · Moderate risk Terminated Jul 2, 2013 HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43199001401 Reason Labeling: Label Mixup; HYOSCYAMINE SULFATE ER Tablet, 0.375 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204… Aidapak Services, LLC D-559-2014
Class II · Moderate risk Terminated Jun 17, 2013 Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg… Reason Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In… Physicians Total Care, Inc. NDC 54868-0031-04 D-826-2013
Class II · Moderate risk Terminated Jan 7, 2013 Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with… Reason Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets. West-ward Pharmaceutical Corp. NDC 0143-1140-10 D-170-2013