Class I - Dangerous
Labeling: Label Mix-Up
💊
Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Class I - Dangerous
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Tablet/Capsule Specifications
Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01
Safecor Health
Class I - Dangerous
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01
Safecor Health
Class I - Dangerous
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class I - Dangerous
Lack of Sterility Assurance
Class I - Dangerous
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class I - Dangerous
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class I - Dangerous
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01
Safecor Health
Class I - Dangerous
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01
Safecor Health
Class I - Dangerous
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
The Harvard Drug Group LLC
Class I - Dangerous
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Class I - Dangerous
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class I - Dangerous
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
VIONA PHARMACEUTICALS
Class I - Dangerous
Crystallization
Class I - Dangerous
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.