Class I - Dangerous
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class I - Dangerous
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class I - Dangerous
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Class I - Dangerous
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Class I - Dangerous
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection.
L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Bella Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility.
Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Bella Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility.
Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Bella Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility.
Class I - Dangerous
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA.
Bella Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility.
Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Bella Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility.
Class I - Dangerous
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class I - Dangerous
PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.
Bella Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility.
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
Aidarex Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Bella Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility.
Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Bella Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility.
Class I - Dangerous
Microbial contamination of Non-sterile Products; potential B. cepacia contamination