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Drug recalls

Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class I April 17, 2024 Methocarbamol Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25… Presence of Particulate Matter Eugia US LLC Ongoing
Class II April 17, 2024 Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin… Subpotent Drug Lupin Pharmaceuticals Inc. Terminated
Class II April 17, 2024 Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent… CGMP Deviations NATCO Pharma Limited Terminated
Class II April 17, 2024 Isotretinoin Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only,… Superpotent Drug: The 3-month stability result for assay was found to be above specification limit Teva Pharmaceuticals USA, Inc Ongoing
Class II April 10, 2024 FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total… Lack of Assurance of Sterility: Firm did not perform process validation. SSM Health Care St. Louis DBA SSM St. Clare Health Center Ongoing
Class II April 10, 2024 fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose… Lack of Assurance of Sterility: leaking bags IntegraDose Compounding Services LLC Ongoing
Class II April 10, 2024 Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only,… Lack of Assurance of Sterility: Firm did not perform process validation. SSM Health Care St. Louis DBA SSM St. Clare Health Center Ongoing
Class III April 10, 2024 Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single… Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation,… X-Gen Pharmaceuticals Inc. Terminated
Class III April 10, 2024 Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard… Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation,… X-Gen Pharmaceuticals Inc. Terminated
Class II April 10, 2024 Lactated Ringers Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc.,… Lack of assurance of sterility: bags have the potential to leak.. B. Braun Medical Inc Terminated
Class II April 10, 2024 Diltiazem Hydrochloride Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100… Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month… Glenmark Pharmaceuticals Inc., USA Ongoing
Class II April 3, 2024 PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL)… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL),… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration =… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration =… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 Tri-Lo-Sprintec Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen,… Failed Dissolution Specifications Teva Pharmaceuticals USA, Inc Terminated
Class II April 3, 2024 fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL)… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL),… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class I April 3, 2024 Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion… Presence of Particulate Matter. Par Sterile Products LLC Ongoing
Class II April 3, 2024 PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration =… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL)… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection,… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only,… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml)… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only,… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100… Lack of Assurance of Sterility SCA Pharmaceuticals, LLC Terminated
Class II April 3, 2024 VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single… cGMP Diviations Apothecus Pharmaceutical Corp. Terminated
Class II April 3, 2024 Divalproex Sodium Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets,… Failed dissolution specifications Amneal Pharmaceuticals of New York, LLC Terminated
Class II March 27, 2024 nicardipine hydrochloride Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only,… Failed Impurities/Degradation Specifications: Out of specification for organic impurities Eugia US LLC Ongoing
Class I March 27, 2024 Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed… Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in… Super Chill Products Terminated
Class II March 27, 2024 nicardipine hydrochloride Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by:… Failed Impurities/Degradation Specifications: Out of specification for organic impurities Eugia US LLC Ongoing
Class III March 27, 2024 Digoxin Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by:… Cross Contamination with Other Products:(mycophenolate mofetil). Novitium Pharma LLC Terminated
Class II March 27, 2024 Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only,… The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual… Hikma Pharmaceuticals USA Inc. Ongoing
Class II March 20, 2024 POTASSIUM CHLORIDE Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag,… Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the… B. Braun Medical Inc Terminated
Class II March 20, 2024 Febuxostat Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for:… CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC Ongoing
Class II March 20, 2024 Febuxostat Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for:… CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC Ongoing
Class II March 20, 2024 Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl),… Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug… Global Corporation Ongoing
Class II March 20, 2024 TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL),… Lack of Assurance of Sterility Optikem International, Inc. Ongoing
Class II March 20, 2024 TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP… Lack of Assurance of Sterility Optikem International, Inc. Ongoing
Class II March 20, 2024 TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL),… Lack of Assurance of Sterility Optikem International, Inc. Ongoing
Class II March 20, 2024 hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle,… Lack of Assurance of Sterility Optikem International, Inc. Ongoing
Class II March 20, 2024 Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL,… cGMP Deviations: Products were stored outside the drug label specifications. Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II March 20, 2024 TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL),… Lack of Assurance of Sterility Optikem International, Inc. Ongoing
Class II March 20, 2024 TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured… Lack of Assurance of Sterility Optikem International, Inc. Ongoing
Class II March 20, 2024 TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL),… Lack of Assurance of Sterility Optikem International, Inc. Ongoing
Class II March 20, 2024 TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for… Lack of Assurance of Sterility Optikem International, Inc. Ongoing
Class II March 20, 2024 TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for… Lack of Assurance of Sterility Optikem International, Inc. Ongoing
Class II March 20, 2024 Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter… cGMP Deviations: Products were stored outside the drug label specifications. Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II March 20, 2024 TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured… Lack of Assurance of Sterility Optikem International, Inc. Ongoing
Class II March 20, 2024 Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate),… Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug… Global Corporation Ongoing
Class II March 20, 2024 BETIMOL Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea… Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. Thea Pharma, Inc. Terminated
Class II March 20, 2024 Tobramycin Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For… Failed Stability Specification: Water determination was found not complying with specification. Eugia US LLC Terminated
Class II March 20, 2024 ROCURONIUM BROMIDE Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx… cGMP Deviations: Products were stored outside the drug label specifications. Mckesson Medical-Surgical Inc. Corporate Office Terminated
Class II March 20, 2024 Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro… Failed Stability Specifications: Out of specification for blend uniformity. Micro Labs Limited Terminated
Class III March 13, 2024 Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for:… Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint. Contract Pharmaceuticals Limited Canada Ongoing
Class III March 13, 2024 Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and… Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint. Contract Pharmaceuticals Limited Canada Ongoing
Class III March 13, 2024 Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b)… Failed Dissolution Specifications: results slightly under spec at at 9-months. Stason Pharmaceuticals, Inc. Terminated
Class II March 13, 2024 Methylprednisolone acetate Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL… Failed Dissolution Specifications Eugia US LLC Ongoing
Class II March 6, 2024 Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose… Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. Denver Solutions, LLC DBA Leiters Health Ongoing
Class II March 6, 2024 Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd,… Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. Denver Solutions, LLC DBA Leiters Health Ongoing
Class II March 6, 2024 Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection,… Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. Denver Solutions, LLC DBA Leiters Health Ongoing
Class II March 6, 2024 CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7%… Lack of Assurance of Sterility Brassica Pharma Pvt Ltd Ongoing
Class II March 6, 2024 Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in… Lack of Assurance of Sterility Brassica Pharma Pvt Ltd Ongoing
Class II March 6, 2024 Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged… Lack of Assurance of Sterility Brassica Pharma Pvt Ltd Ongoing
Class II March 6, 2024 Mesalamine Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle,… Failed Dissolution Specifications: Out of specification for dissolution. SUN PHARMACEUTICAL INDUSTRIES INC Ongoing
Class II March 6, 2024 PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser,… CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. Seatex LLC Terminated
Class II March 6, 2024 Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5… Lack of Assurance of Sterility Brassica Pharma Pvt Ltd Ongoing
Class II March 6, 2024 7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain… CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. Seatex LLC Terminated
Class II March 6, 2024 PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic,… CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. Seatex LLC Terminated
Class II March 6, 2024 PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex… CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. Seatex LLC Terminated
Class II March 6, 2024 7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL… CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. Seatex LLC Terminated
Class II March 6, 2024 Fluticasone Propionate Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net… CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex Golden State Medical Supply Inc. Ongoing
Class II March 6, 2024 Omeprazole and Sodium Bicarbonate Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains… Subpotent Drug: Out of specification for assay Bausch Health Companies, Inc. Completed
Class II February 28, 2024 OSELTAMIVIR PHOSPHATE Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only,… Failed Impurities/Degradation Specifications: Out-of-specification test results. Amneal Pharmaceuticals of New York, LLC Terminated
Class I February 28, 2024 SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by:… Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an… Today The World Ongoing
Class I February 28, 2024 Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD… Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an… Today The World Ongoing
Class I February 28, 2024 Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural… Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an… Today The World Ongoing
Class I February 28, 2024 Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed… Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in… Neptune Resources, LLC Ongoing
Class I February 28, 2024 Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake,… Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in… Neptune Resources, LLC Ongoing
Class I February 28, 2024 Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By… Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in… Neptune Resources, LLC Ongoing
Class II February 28, 2024 Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290… CGMP Deviations Alpha Aromatics Terminated
Class II February 28, 2024 Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag,… CGMP Deviations: Potential Glass and Silicone particulates in product Bestco LLC Terminated
Class II February 28, 2024 Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per… CGMP Deviations: Potential Glass and Silicone particulates in product Bestco LLC Terminated
Class II February 28, 2024 Fosfomycin Tromethamine Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of… Failed Impurities/Degradation Specification: Out of specification for organic impurities Ascend Laboratories, LLC Ongoing
Class I February 28, 2024 TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g)… Chemical Contamination; presence of benzene. Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company Completed
Class II February 28, 2024 Voriconazole Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted.… Labeling: Incorrect or Missing Package Insert Lupin Pharmaceuticals Inc. Terminated
Class II February 28, 2024 Adrenalin Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By:… Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect. Henry Schein Inc. and Glove Club HSI Gloves Inc. Completed
Class II February 28, 2024 Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag,… CGMP Deviations: Potential Glass and Silicone particulates in product Bestco LLC Terminated
Class II February 28, 2024 Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops… CGMP Deviations: Potential Glass and Silicone particulates in product Bestco LLC Terminated
Class II February 28, 2024 CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel… CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled… MCKESSON CORPORATION Terminated
Class II February 28, 2024 CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per… CGMP Deviations: Potential Glass and Silicone particulates in product Bestco LLC Terminated
Class II February 28, 2024 norepinephrine bitartrate Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For… Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength… Baxter Healthcare Corporation Ongoing
Class II February 28, 2024 Clobazam Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited… CGMP Deviations: Out of specification for residual solvents. Micro Labs Limited Ongoing
Class II February 28, 2024 Acthar Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL… cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has… Mallinckrodt Hospital Products Inc. Ongoing
Class II February 28, 2024 Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only,… cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has… Mallinckrodt Hospital Products Inc. Ongoing
Class II February 28, 2024 Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx… CGMP Deviations: potential presence of Burkholderia cepacia complex Apotex Corp. Ongoing
Class II February 21, 2024 Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection,… Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date. IntegraDose Compounding Services LLC Ongoing
Class II February 21, 2024 HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards),… an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility… The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Terminated
Class III February 21, 2024 Nortrel 7/7/7 Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen),… Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. Teva Pharmaceuticals USA, Inc Ongoing
Class III February 21, 2024 Nortrel Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons,… Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. Teva Pharmaceuticals USA, Inc Ongoing
Class III February 14, 2024 Glimepiride Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's… Misprint on tablet Dr. Reddy's Laboratories, Inc. Ongoing
Class III February 14, 2024 Glimepiride Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's… Misprint on tablet Dr. Reddy's Laboratories, Inc. Ongoing
Class I February 14, 2024 Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%,… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%),… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a)… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%),… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%,… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a)… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL)… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL)… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL)… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class II February 14, 2024 Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only,… Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. Amneal Pharmaceuticals of New York, LLC Terminated
Class I February 14, 2024 Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL)… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class II February 14, 2024 Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials CGMP Deviations OMEZA LLC Terminated
Class II February 14, 2024 Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS CGMP Deviations OMEZA LLC Terminated
Class I February 14, 2024 Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%)… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class I February 14, 2024 Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%,… Non-Sterility Kilitch Healthcare India Limited Ongoing
Class II February 14, 2024 Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco… CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules… NATCO Pharma Limited Terminated
Class II February 14, 2024 Febuxostat Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by:… CGMP Deviations Amerisource Health Services LLC Terminated
Class II February 14, 2024 Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL… Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in… MEDLINE INDUSTRIES, LP - Northfield Ongoing
Class III February 14, 2024 HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton,… Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related… Amerisource Health Services LLC Terminated
Class I February 7, 2024 FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item… Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV… Denver Solutions, LLC DBA Leiters Health Ongoing
Class I February 7, 2024 PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for… Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV… Denver Solutions, LLC DBA Leiters Health Ongoing
Class I February 7, 2024 PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for… Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV… Denver Solutions, LLC DBA Leiters Health Ongoing
Class I February 7, 2024 VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV… Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV… Denver Solutions, LLC DBA Leiters Health Ongoing
Class II February 7, 2024 Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol… CGMP Deviations: products may not conform to the labeled specifications. Den-Mat Holdings, LLC Ongoing
Class II February 7, 2024 OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0%… CGMP Deviations: products may not conform to the labeled specifications. Den-Mat Holdings, LLC Ongoing
Class I February 7, 2024 VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV… Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV… Denver Solutions, LLC DBA Leiters Health Ongoing
Class I February 7, 2024 FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item… Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV… Denver Solutions, LLC DBA Leiters Health Ongoing
Class II February 7, 2024 rifampin Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only,… Failed Impurities/Degradation Specification. Amerisource Health Services LLC Terminated
Class I February 7, 2024 Zenzedi Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only,… Labeling: Label Mix-up Azurity Pharmaceuticals, Inc. Terminated
Class II February 7, 2024 CEFIXIME Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin… Failed Impurities/Degradation Specifications Lupin Pharmaceuticals Inc. Terminated
Class II February 7, 2024 Budesonide Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by:… Failed Dissolution Specifications Teva Pharmaceuticals USA, Inc Ongoing
Class II February 7, 2024 Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS,… Failed Dissolution Specifications Golden State Medical Supply Inc. Terminated
Class II February 7, 2024 rifampin Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin… Subpotent Drug and Failed Impurities/Degradation Specifications Lupin Pharmaceuticals Inc. Terminated
Class II February 7, 2024 rifampin Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin… Subpotent Drug and Failed Impurities/Degradation Specifications Lupin Pharmaceuticals Inc. Terminated
Class II January 31, 2024 Zolpidem Tartrate Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle,… CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC Completed
Class II January 31, 2024 NIACIN Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed… CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC Completed
Class II January 31, 2024 Febuxostat Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun… CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC Completed
Class I January 31, 2024 BLEOMYCIN Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx… Presence of particulate matter: glass PFIZER Ongoing
Class I January 31, 2024 Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg),… Microbial Contamination of Non-Sterile Products Haleon US Holdings LLC Ongoing
Class I January 31, 2024 Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20… Microbial Contamination of Non-Sterile Products Haleon US Holdings LLC Ongoing
Class II January 31, 2024 Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota… Subpotent Drug IntegraDose Compounding Services LLC Ongoing
Class III January 31, 2024 Benzonatate Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx… Superpotent drug: Assay results were slightly above specification at the time zero point. Amerisource Health Services LLC Ongoing
Class II January 31, 2024 Febuxostat Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun… CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC Completed
Class II January 31, 2024 Cinacalcet Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun… CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC Completed
Class II January 31, 2024 fluocinolone acetonide Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume)… Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol Glenmark Pharmaceuticals Inc., USA Terminated
Class II January 31, 2024 Mesalamine Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per… CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC Completed
Class II January 31, 2024 NIACIN Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed… CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC Completed
Class II January 31, 2024 Fosaprepitant Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous… Lack of Sterility Assurance: Aseptic process simulation failure. BE PHARMACEUTICALS AG Terminated
Class II January 31, 2024 Zolpidem Tartrate Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle,… CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC Completed
Class II January 31, 2024 LURASIDONE HYDROCHLORIDE Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by:… CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC Completed
Class II January 31, 2024 Fexofenadine Hydrochloride Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30… CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC Completed
Class II January 31, 2024 LURASIDONE HYDROCHLORIDE Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by:… CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. SUN PHARMACEUTICAL INDUSTRIES INC Completed
Class II January 31, 2024 Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma… Failed Dissolution Specifications Strides Pharma Inc. Terminated
Class II January 24, 2024 Secret, powder fresh, (Aluminum chlorohydrate 24%), Anti-Perspirant/Deodorant, Topical… CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl.… MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Pharma Nobis LLC Ongoing
Class II January 24, 2024 Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Cherry… MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Pharma Nobis LLC Ongoing
Class II January 24, 2024 Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape… MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Pharma Nobis LLC Ongoing
Class I January 24, 2024 Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical spray can… Chemical contamination: presence of benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 Secret Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical spray can… CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene The Procter & Gamble Company Terminated
Class I January 24, 2024 Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate 23.5%),… Chemical contamination: presence of benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Light Essentials,… CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 Secret, OUTLAST, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Completely… CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene The Procter & Gamble Company Terminated
Class I January 24, 2024 Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Lavender, Topical spray… Chemical contamination: presence of benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 Old Spice, SWEAT DEFENSE, STRONGER SWAGGER, Dry Spray, 48 Hour, (Aluminum Chlorohydrate… CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray,… CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Anti-Perspirant,… CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 Old Spice, SWEAT DEFENSE PURE SPORT PLUS, (Aluminum Chlorohydrate 23.5%),… CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Lavender, Topical… CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 Secret OUTLAST Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Protecting… CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 Secret, Dry Spray, Aluminum chlorohydrate 23.5% Antiperspirant, Waterlily, Topical Spray… CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 Old Spice Pure Sport 2021 Gift Set, Contains: Old Spice Pure Sport Body Wash 18 Fl Oz… CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene The Procter & Gamble Company Terminated
Class I January 24, 2024 Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Anti-Perspirant,… Chemical contamination: presence of benzene The Procter & Gamble Company Terminated
Class I January 24, 2024 Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Waterlily, Topical… Chemical contamination: presence of benzene The Procter & Gamble Company Terminated
Class I January 24, 2024 Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray,… Chemical contamination: presence of benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxative, Oral… MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Pharma Nobis LLC Ongoing
Class II January 24, 2024 Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low… MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Pharma Nobis LLC Ongoing
Class I January 24, 2024 Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57… Chemical Contamination: presence of benzene Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company Completed
Class I January 24, 2024 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of… Presence of Particulate Matter; identified as glass Pfizer Inc. Ongoing
Class I January 24, 2024 SODIUM BICARBONATE 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass… Presence of Particulate Matter; identified as glass Pfizer Inc. Ongoing
Class I January 24, 2024 ATROPINE SULFATE Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit… Presence of Particulate Matter; identified as glass Pfizer Inc. Ongoing
Class II January 24, 2024 Ibuprofen and famotidine Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle,… Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of… Ascend Laboratories, LLC Ongoing
Class I January 24, 2024 Secret, powder fresh, Aluminum chlorohydrate 24%, Anti-Perspirant/Deodorant, Topical… Chemical contamination: presence of benzene The Procter & Gamble Company Terminated
Class II January 24, 2024 Vasostrict Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per… Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit. Par Sterile Products LLC Ongoing
Class II January 17, 2024 Tacrolimus Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's… Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules. Dr. Reddy's Laboratories, Inc. Terminated
Class I January 17, 2024 vigabatrin Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only,… Defective Container: powder may leak out of the pouch InvaGen Pharmaceuticals, Inc. Completed
Class II January 17, 2024 bupropion hydrochloride buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx… Presence of Foreign Tablets/Capsules Rising Pharma Holding, Inc. Ongoing
Class II January 17, 2024 DESLORATADINE Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC… CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit. Lupin Pharmaceuticals Inc. Terminated
Class II January 17, 2024 Tizanidine Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories… Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets. Dr. Reddy's Laboratories, Inc. Completed
Class II January 10, 2024 Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant,… CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the… Seaway Pharma Inc. Ongoing
Class II January 10, 2024 Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride… CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the… Seaway Pharma Inc. Ongoing
Class II January 10, 2024 Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride… CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the… Seaway Pharma Inc. Ongoing
Class II January 10, 2024 Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL… CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the… Seaway Pharma Inc. Ongoing
Class III January 10, 2024 Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for:… Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result… Azurity Pharmaceuticals, Inc. Terminated
Class II January 10, 2024 DELFLEX DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in… Lack of Sterility Assurance Fresenius Medical Care Holdings, Inc. Ongoing
Class II January 3, 2024 Sertraline Hydrochloride Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart,… CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. Legacy Pharmaceutical Packaging LLC Ongoing
Class II January 3, 2024 Donepezil Hydrochloride Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S.… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class I January 3, 2024 Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum… Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) -… Meta Herbal Ongoing
Class II January 3, 2024 Folic Acid FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only,… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 Albuterol Sulfate ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 doxycycline Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class I January 3, 2024 Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4… Chemical contamination: Presence of benzene TCP HRB ACQUISITON LLC Ongoing
Class I January 3, 2024 Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged… Chemical contamination: Presence of benzene TCP HRB ACQUISITON LLC Ongoing
Class II January 3, 2024 Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn,… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class I January 3, 2024 Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6… Chemical contamination: Presence of benzene TCP HRB ACQUISITON LLC Ongoing
Class II January 3, 2024 Chlorthalidone CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: Appco Pharma… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by:… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint,… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 Citalopram CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 Warfarin Sodium Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for:… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer:… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 meloxicam Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial,… Presence of Particulate Matter. AnazaoHealth Corporation Terminated
Class II January 3, 2024 Warfarin Sodium Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For:… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 Enoxaparin Sodium Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety… CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE Terminated
Class II January 3, 2024 B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI… Presence of Particulate Matter. AnazaoHealth Corporation Terminated