Class I - Dangerous
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC 0597-0175-18
Boehringer Ingelheim Pharmaceuticals
Class I - Dangerous
Cross Contamination With Other Products:
Class I - Dangerous
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Class I - Dangerous
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class I - Dangerous
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30
Hetero Labs Limited Unit V
Class I - Dangerous
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90
Hetero Labs, Ltd. - Unit III
Class I - Dangerous
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Class I - Dangerous
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class I - Dangerous
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153
Dr. Reddy's Laboratories
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class I - Dangerous
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Class I - Dangerous
Subpotent Drug: Product may not have the active ingredient present in the bag.