Class II · Moderate risk Ongoing
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03)…
Reason Presence of Foreign Substance
FDA Drug Recalls
404 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL…
Reason sub potency
Class II · Moderate risk Ongoing
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India…
Reason Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Class II · Moderate risk Ongoing
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC…
Reason Presence of Foreign Substance.
Class II · Moderate risk Ongoing
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC…
Reason Presence of Foreign Substance.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10)…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g)…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units)…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta…
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class II · Moderate risk Ongoing
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL…
Reason Incorrect product formulation: bag did not contain copper and famotidine per label.