Class III · Low risk
Ciprofloxacin Tablets
Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX
Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
Class II · Moderate risk
Nisoldipine Extended Release Tablets
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
Class II · Moderate risk
Thyro-Tab.075 mg.
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
Class II · Moderate risk
Levothroid
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
Class I · High risk
Japan Weight Loss Blue Capsules
Marketed Without an Approved ANDA/NDA: presence of sibutramine
Class I · High risk
Man King Capsules
Marketed Without an Approved ANDA/NDA: presence of sildenafil.
Class I · High risk
Hard Ten Days Capsule
Marketed Without an Approved ANDA/NDA: presence of sildenafil
Class II · Moderate risk
Physicians Total Care
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Class II · Moderate risk
Physicians Total Care
Presence of Foreign Substance(s): There is a potential for foreign particulate matter in the API.
Class II · Moderate risk
Lipitor (Atorvastatin calcium)
Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.
Class II · Moderate risk
Eloxatin (OXALIplatin injection)
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.
Class II · Moderate risk
Eloxatin (OXALIplatin injection)
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.
Class II · Moderate risk
Levothroid
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
Class II · Moderate risk
Thyro-Tab 0.050mg.
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
Class I · High risk
Actra-SX 500 Capsules
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Class I · High risk
Argatroban Injection 50 mg per 50ml
A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Class II · Moderate risk
Hipoglos Ointment
Misbranded
Class II · Moderate risk
ChloraPrep with Tint
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Class II · Moderate risk
Prefera OB One Gel Capsules
Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP.
Class II · Moderate risk
Xactdose Phenytoin Oral Suspension
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
Class II · Moderate risk
Docusate Calcium Softgel Capsules
Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
Class I · High risk
metFORMIN ER Tablets
Labeling: Label Mix up; product labeled did not indicated Extended Release