Class II · Moderate risk
Progesterone 200 mg Troche
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
FDA Drug Recalls
1,293 recalls, newest first
Class II · Moderate risk
Naltrexone 4.5 mg capsule
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Magic Bullet Supplement
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Liothyronine
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Liothyronine
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Finasteride/Biotin 1 mg/50 mcg
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
DHEA/Pregnenol One 10.25 MG Cap
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
25% Dextrose Injection
Labeling: Incorrect or Missing Lot and/or expiration date.
Class I · High risk
Mirtazapine Tablets
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Class I · High risk
Mirtazapine Tablets
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Class III · Low risk
Timolol Maleate Sterile Opthalmic Solution
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Class III · Low risk
Timolol Maleate USP
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Class III · Low risk
Colostat
Labeling mix-up - Indications on product label are incorrect.
Class II · Moderate risk
MYORISAN (isotretinoin capsules, USP)
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
Class III · Low risk
PF-Succinylcholine Chloride Injection
Incorrect labeling: Incorrect or missing lot and/or exp date
Class III · Low risk
Gatifloxacin Ophthalmic Solution 0.5%
Labeling: Incorrect or missing package insert.
Class III · Low risk
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension
Labeling: Incorrect or missing package insert.
Class III · Low risk
Bimatoprost Ophthalmic Solution 0.03%
Labeling: Incorrect or missing package insert.
Class III · Low risk
Levetiracetam Injection
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Class III · Low risk
Testosterone Cypionate Injection
Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
Class II · Moderate risk
Vivitrol (naltrexone for extended-release injectable suspension)
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Class III · Low risk
Sodium Chloride Injection USP 0.9%
Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
Class II · Moderate risk
Optiray 320
Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.