Lack of Assurance of Sterility
Prescription Drugs
💊 Drugs • 12,141 recalls
Lack of Assurance of Sterility
Glauco-Catar Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Herbal Doctor Remedies
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Stone Purger Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Herbal Doctor Remedies
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Lack of Processing Controls
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
Subpotent Drug
Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.
Wise Pharmacy
Lack of Processing Controls
Lack of Processing Controls
Failed dissolution specifications : failed results at the 3-month stability time point.
Lack of Processing Controls
Lack of Processing Controls
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11
American Health Packaging
Failed Dissolution Specifications: Out of specification result for the dissolution test.
Lack of Processing Controls
Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Wise Pharmacy
Lack of Processing Controls
Lack of Processing Controls
Subpotent Drug
Lack of Processing Controls
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.