Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Class I - Dangerous
Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Class I - Dangerous
Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
Class I - Dangerous
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs Abilify Tablets 10 mg (14 day supply) plus 1 Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850 USA Marketed by: Lundbleck, Deerfield, IL 60015 USA Bar Code VialKit-59148-10Tabs-02
Otsuka Pharmaceutical Development & Commercialization
Class I - Dangerous
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850. Marketed by: Deerfield, IL 60015 USA. Bar Code DCSKit-59148-10Tabs-01
Otsuka Pharmaceutical Development & Commercialization
Class I - Dangerous
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
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
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 .