Class I - Dangerous
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
Impurities/Degradation Products: exceeded specification at 3 month stability testing
Class I - Dangerous
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.
Watson Laboratories
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01
Watson Laboratories
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class I - Dangerous
Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01
Watson Laboratories
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA
Mcneil Consumer Healthcare, Div Of Mcneil-ppc
Class I - Dangerous
Defective Container; damaged blister units
Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA.
Health Plus Incorporated
Class I - Dangerous
Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.
Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10
sanofi-aventis US
Class I - Dangerous
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01
Watson Laboratories
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
sanofi-aventis US
Class I - Dangerous
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01
Watson Laboratories
Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class I - Dangerous
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
Class I - Dangerous
Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
Class I - Dangerous
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
Class I - Dangerous
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point