Prescription and over-the-counter medications
Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot.
Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Paddock Laboratories
Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because of a non-conformity dissolution failure result found during routine stability testing at the 6 month test interval.
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Mylan Pharmaceuticals
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
www.vitaminbestbuy.com
Marketed Without an Approved ANDA/NDA: presence of sibutramine
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Marketed Without an Approved ANDA/NDA: presence of sildenafil.
Glenmark Generics Inc., USA
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol
Abbott Laboratories
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Abbott Laboratories
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Abbott Laboratories
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Marketed Without an Approved ANDA/NDA: presence of sildenafil