Class I - Dangerous
Lack of Sterility Assurance
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Prescription Drugs
💊 Drugs • 12,141 recalls
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.
Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specification
Class I - Dangerous
Labeling: Missing Label
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
Staska Pharmaceuticals
Class I - Dangerous
Presence of Particulate Matter: Presence of glass particulates.
Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.
Dr. Reddy's Laboratories
Class I - Dangerous
Failed Impurities/Degradation Specification
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
BLI International
Class I - Dangerous
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Class I - Dangerous
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.