Class II · Moderate risk Completed
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of…
Reason Subpotent Drug: Out of specification for assay
FDA Drug Recalls
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Class I · High risk Ongoing
To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity…
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I · High risk Ongoing
RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed…
Reason Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
Class I · High risk Completed
TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight…
Reason Chemical Contamination; presence of benzene.
Class III · Low risk Ongoing
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health…
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the…
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India…
Reason CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking…
Class II · Moderate risk Ongoing
Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park…
Reason CGMP Deviations
Class III · Low risk Ongoing
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6…
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk Ongoing
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each…
Reason Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class II · Moderate risk Terminated
Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx…
Reason Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the…
Class II · Moderate risk Ongoing
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only…
Reason Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Class II · Moderate risk Terminated
Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per…
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk Terminated
Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288…
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk Terminated
Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288…
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk Terminated
Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288…
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk Terminated
CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288…
Reason CGMP Deviations: Potential Glass and Silicone particulates in product
Class II · Moderate risk Terminated
Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
Reason CGMP Deviations
Class II · Moderate risk Terminated
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
Reason CGMP Deviations
Class III · Low risk Ongoing
Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA…
Reason Misprint on tablet
Class III · Low risk Ongoing
Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA…
Reason Misprint on tablet