Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Prescription Drugs
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Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Crystallization: Presence of visible particulate matter.
Crystallization: Presence of visible particulate matter.
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Presence of Foreign Substance: Foreign material found inside the vial.
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Crystallization: Presence of visible particulate matter.
DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
AuroMedics Pharma
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01
Preferred Pharmaceuticals
Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy
New Vitalis Pharmacy LLC
Lack of sterility assurance.
Calcarea Sulphurica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64190 3.
Washington Homeopathic Products
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35
Altaire Pharmaceuticals
Lack of Assurance of Sterility