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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 II January 18, 2023 TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only,… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine)… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE,… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine)… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine)… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine)… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine)… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine)… Lack of Assurance of Sterility Northern VA Compounders PLLC Terminated
Class II January 18, 2023 Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By:… cGMP deviation: discontinue of stability support for product. Direct Rx Terminated
Class II January 18, 2023 Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5… Lack of Assurance of Sterility Nephron Sterile Compounding Center LLC Terminated
Class II January 18, 2023 rifampin Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin… Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability… Lupin Pharmaceuticals Inc. Terminated
Class II January 11, 2023 Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1… CGMP Deviations: Raw material recalled by repackager, due to discoloration. Pine Pharmaceuticals, LLC Terminated
Class II January 11, 2023 Acyclovir Sodium Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx… Presence of Particulate Matter: Customer complaint of dark particles found inside the vial Eugia US LLC Ongoing
Class III January 11, 2023 Prochlorperazine Maleate Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista… Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. Jubilant Cadista Pharmaceuticals, Inc. Terminated
Class II January 11, 2023 Heparin Sodium Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride… Lack of assurance of sterility: Bags have the potential to leak. Pfizer Inc. Completed
Class II January 4, 2023 Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as… CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits. NCH Life Sciences LLC Completed
Class II January 4, 2023 Ganciclovir Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only,… Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of… Hikma Pharmaceuticals USA Inc. Terminated
Class II January 4, 2023 GLYCOPYRROLATE Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only,… Failed impurities/degradation specifications: Out of specification for unknown impurities. AVKARE LLC Completed
Class III January 4, 2023 Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc.… Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected… Apotex Corp. Terminated
Class II December 28, 2022 Oxcarbazepine Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b)… Presence of foreign substance SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II December 28, 2022 Quinapril Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals,… CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Lupin Pharmaceuticals Inc. Terminated
Class II December 28, 2022 Quinapril Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals,… CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Lupin Pharmaceuticals Inc. Terminated
Class II December 28, 2022 GLYCOPYRROLATE Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma… Failed Impurities/Degradation Specifications Aurolife Pharma, LLC Ongoing
Class II December 21, 2022 ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles,… cGMP Deviations Atlantic Management Resources Ltd. Terminated
Class II December 21, 2022 Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles,… cGMP Deviations Atlantic Management Resources Ltd. Terminated
Class II December 21, 2022 Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles,… cGMP Deviations Atlantic Management Resources Ltd. Terminated
Class I December 21, 2022 Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe,… Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy Terminated
Class II December 21, 2022 Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl.… cGMP Deviations Atlantic Management Resources Ltd. Terminated
Class II December 21, 2022 FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single… Underfilled units. OurPharma LLC Terminated
Class I December 21, 2022 SODIUM BICARBONATE 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials,… Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product… Exela Pharma Sciences LLC Terminated
Class I December 21, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials,… Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product… Exela Pharma Sciences LLC Terminated
Class III December 21, 2022 Lacosamide Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only,… Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content Camber Pharmaceuticals, Inc Terminated
Class II December 14, 2022 Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01;… Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency. RemedyRepack Inc. Terminated
Class II December 14, 2022 SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00… Lack of sterility assurance: Bags have the potential to leak. B. Braun Medical, Inc. Terminated
Class II December 14, 2022 Sodium Chloride 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg,… Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution. Fresenius Medical Care Holdings, Inc. Ongoing
Class II December 7, 2022 desmopressin acetate Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet… Subpotent Drug Heritage Pharmaceuticals Inc Terminated
Class III December 7, 2022 Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net… Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period. Acella Pharmaceuticals, LLC Terminated
Class III December 7, 2022 Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal… Failed dissolution specifications Dr. Reddy's Laboratories, Inc. Terminated
Class II December 7, 2022 Daytrana Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr),… Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related… Noven Pharmaceuticals Inc Ongoing
Class II November 30, 2022 PANTOPRAZOLE SODIUM Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice… Discoloration SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class III November 30, 2022 Phenytoin Sodium Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL… Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial… Acella Pharmaceuticals, LLC Terminated
Class III November 30, 2022 Phenytoin Sodium Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL… Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial… Acella Pharmaceuticals, LLC Terminated
Class II November 23, 2022 Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4… CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same… Adam's Polishes LLC Ongoing
Class I November 23, 2022 Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4… Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75%… Adam's Polishes LLC Ongoing
Class II November 23, 2022 Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx,… Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost. ImprimisRx NJ Terminated
Class II November 23, 2022 PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron… CGMP Deviations: Potential for cross contamination due to product carry over. Nephron Sterile Compounding Center LLC Terminated
Class II November 23, 2022 PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B… CGMP Deviations: Potential for cross contamination due to product carry over. Nephron Sterile Compounding Center LLC Terminated
Class II November 23, 2022 Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by:… Failed Impurities/Degradation Specifications Par Formulations Private Limited Terminated
Class II November 23, 2022 SODIUM CHLORIDE 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical,… Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise… ICU Medical Inc Ongoing
Class II November 23, 2022 Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals… Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness. Viatris Inc Terminated
Class III November 23, 2022 Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100… Failed Stability Specifications Aadi Bioscience Terminated
Class I November 16, 2022 Octreotide Acetate Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For… Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe. Viatris Inc Terminated
Class II November 9, 2022 GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes, Rx… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, Rx only, Vital Care… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital Care… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vital Care… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only,… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only,… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL vials, Rx… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, Vital Care… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials, Rx only,… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers, Rx only, Vital Care… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th Ave.,… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave.,… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder,… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder, 115 S. 40th… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only, Vital… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vital Care… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class II November 9, 2022 CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder,… Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot… Pharmacy Plus, Inc. dba Vital Care Compounder Ongoing
Class III November 9, 2022 Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One… Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients… Genentech Inc Terminated
Class II November 9, 2022 Buprenorphine and Naloxone Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only,… Presence of Foreign Substance SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II November 2, 2022 Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs,… Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the… Ultra Chem Labs Corp Terminated
Class II November 2, 2022 fondaparinux sodium Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe,… Subpotent Drug: Out of specification for assay AuroMedics Pharma LLC Terminated
Class II November 2, 2022 Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs,… Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the… Ultra Chem Labs Corp Terminated
Class II November 2, 2022 Pyridostigmine Bromide Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL… cGMP Deviations: Out of specification for assay of one of the preservative ingredients. VistaPharm, Inc. Terminated
Class I November 2, 2022 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials,… Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product… Exela Pharma Sciences LLC Terminated
Class I November 2, 2022 SODIUM BICARBONATE 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials,… Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product… Exela Pharma Sciences LLC Terminated
Class I November 2, 2022 Atenolol Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY… Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets Golden State Medical Supply Inc. Terminated
Class II November 2, 2022 QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles… CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Aurobindo Pharma USA Inc. Completed
Class II October 26, 2022 Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon… Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for… Golden State Medical Supply Inc. Terminated
Class II October 26, 2022 Acyclovir Sodium Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only,… Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial. AuroMedics Pharma LLC Completed
Class II October 26, 2022 Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b)… Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for… Golden State Medical Supply Inc. Terminated
Class II October 26, 2022 Flunisolide Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus… Out of specification for related substances (impurities). Ingenus Pharmaceuticals Llc Completed
Class II October 26, 2022 Sodium Chloride 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg,… Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution. Fresenius Medical Care Holdings, Inc. Ongoing
Class III October 26, 2022 NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER… Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg LNK International, Inc. Terminated
Class II October 19, 2022 Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified… Marketed Without An Approved NDA/ANDA; Unapproved new drug Justified Laboratories Terminated
Class II October 19, 2022 Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified… Marketed Without An Approved NDA/ANDA; Unapproved new drug Justified Laboratories Terminated
Class I October 12, 2022 Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in… Chemical Contamination: product found to contain benzene Salon Technologies International Inc Terminated
Class III October 12, 2022 Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250… Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label. Woodbine Products Co Inc Terminated
Class II October 12, 2022 Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon… GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. Salon Technologies International Inc Terminated
Class III October 12, 2022 Phytonadione Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton,… Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum… Dr. Reddy's Laboratories, Inc. Completed
Class II October 12, 2022 arformoterol tartrate Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial… Lack of Assurance of Sterility: environmental monitoring failure. CIPLA Terminated
Class III October 12, 2022 Tranexamic Acid Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx… Presence of Particulate Matter: Piece of metal found in a vial AuroMedics Pharma LLC Ongoing
Class II October 12, 2022 Aminophylline Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only,… Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial. Pfizer Inc. Terminated
Class III October 5, 2022 Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories,… Failed Viscosity specification: Slightly higher OOS results obtained for viscosity ALMIRALL, LLC Terminated
Class II October 5, 2022 Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating… Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for… Akorn, Inc. Ongoing
Class III October 5, 2022 oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV… Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of… QuVa Pharma, Inc. Terminated
Class II October 5, 2022 Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle… Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for… Akorn, Inc. Ongoing
Class II October 5, 2022 Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials… Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial. Viatris Inc Terminated
Class III October 5, 2022 Esomeprazole Magnesium Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per… Superpotent Drug: Out of specification for assay at the 12-month timepoint. SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class III October 5, 2022 Esomeprazole Magnesium Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per… Superpotent Drug: Out of specification for assay at the 12-month timepoint. SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class III October 5, 2022 Clomipramine Hydrochloride ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING… Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules Leading Pharma, LLC Terminated
Class II October 5, 2022 Budesonide Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x… Lack of Assurance of Sterility CIPLA Terminated
Class II October 5, 2022 Neoral Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30… CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content. Novartis Pharmaceuticals Corporation Terminated
Class III September 28, 2022 Clonidine Hydrochloride Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by:… Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine… UNICHEM PHARMACEUTICALS USA INC Terminated
Class II September 21, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 FL OZ (296… CGMP Deviations Vi-Jon, LLC Terminated
Class I September 21, 2022 Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz),… Microbial contamination of non-sterile products. Vi-Jon, LLC Terminated
Class II September 21, 2022 TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore,… Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. RemedyRepack Inc. Terminated
Class II September 21, 2022 Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or… Lack of Assurance of Sterility Pine Pharmaceuticals, LLC Terminated
Class II September 21, 2022 TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only,… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina… Lack of Assurance of Sterility Carolina Infusion Completed
Class II September 21, 2022 L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees… Lack of Assurance of Sterility Carolina Infusion Completed
Class I September 21, 2022 CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon… Microbial contamination of non-sterile products. Vi-Jon, LLC Terminated
Class I September 21, 2022 Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%,… Chemical contamination: presence of benzene Edgewell Personal Care Brands, LLC Terminated
Class II September 21, 2022 Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially… CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above… SUPERIOR GLOVE WORKS, LTD. Terminated
Class II September 21, 2022 Triamcinolone Acetonide Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By:… CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. Direct Rx Completed
Class I September 21, 2022 meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor,… Microbial contamination of non-sterile products. Vi-Jon, LLC Terminated
Class I September 21, 2022 Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz),… Microbial contamination of non-sterile products. Vi-Jon, LLC Terminated
Class II September 21, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 FL OZ (296… CGMP Deviations Vi-Jon, LLC Terminated
Class I September 21, 2022 equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), Grape Flavor,… Microbial contamination of non-sterile products. Vi-Jon, LLC Terminated
Class II September 21, 2022 Lisinopril Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin… Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. Lupin Pharmaceuticals Inc. Terminated
Class I September 21, 2022 SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemony… Microbial contamination of non-sterile products. Vi-Jon, LLC Terminated
Class I September 21, 2022 Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor,… Microbial contamination of non-sterile products. Vi-Jon, LLC Terminated
Class I September 21, 2022 Topcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz),… Microbial contamination of non-sterile products. Vi-Jon, LLC Terminated
Class I September 21, 2022 EQUALINE magnesium citrate saline laxative, oral solution, (1.745 g/fl oz), DYE FREE… Microbial contamination of non-sterile products. Vi-Jon, LLC Terminated
Class I September 21, 2022 P, magnesium citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL… Microbial contamination of non-sterile products. Vi-Jon, LLC Terminated
Class I September 21, 2022 Kroger, Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ… Microbial contamination of non-sterile products. Vi-Jon, LLC Terminated
Class II September 21, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296… CGMP Deviations Vi-Jon, LLC Terminated
Class I September 21, 2022 propofol PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop… Presence of particulate matter Pfizer Inc. Terminated
Class II September 21, 2022 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and… Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets… Teva Pharmaceuticals USA Inc Terminated
Class II September 14, 2022 Difluprednate Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla… Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes… CIPLA Terminated
Class II September 14, 2022 Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan… Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes… CIPLA Terminated
Class II September 14, 2022 Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by:… cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include… Akorn, Inc. Terminated
Class II September 14, 2022 Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by:… cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include… Akorn, Inc. Terminated
Class II September 14, 2022 Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray,… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class II September 14, 2022 GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class II September 14, 2022 MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class I September 14, 2022 MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups… Microbial Contamination of Non-Sterile Products Plastikon Healthcare LLC Terminated
Class I September 14, 2022 Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30… Microbial Contamination of Non-Sterile Products. Plastikon Healthcare LLC Terminated
Class II September 14, 2022 GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class II September 14, 2022 Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray,… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class II September 14, 2022 Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class II September 14, 2022 Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class II September 14, 2022 MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class II September 14, 2022 Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class I September 14, 2022 Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30… Microbial Contamination of Non-Sterile Products. Plastikon Healthcare LLC Terminated
Class II September 14, 2022 CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class II September 14, 2022 Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class II September 14, 2022 CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class II September 14, 2022 CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class I September 14, 2022 MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups… Microbial Contamination of Non-Sterile Products. Plastikon Healthcare LLC Terminated
Class II September 14, 2022 Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class II September 14, 2022 CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray,… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately… Plastikon Healthcare LLC Terminated
Class II September 7, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ.… cGMP deviation: Product held outside of appropriate temperature storage conditions. Family Dollar Stores, Llc. Ongoing
Class II September 7, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High… cGMP deviation: Product held outside of appropriate temperature storage conditions. Family Dollar Stores, Llc. Ongoing
Class II September 7, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5%… cGMP deviation: Product held outside of appropriate temperature storage conditions. Family Dollar Stores, Llc. Ongoing
Class II September 7, 2022 Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0… cGMP deviation: Product held outside of appropriate temperature storage conditions. Family Dollar Stores, Llc. Ongoing
Class II September 7, 2022 Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC,… Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol Tsm Brands LLC Ongoing
Class II September 7, 2022 Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355… Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol Tsm Brands LLC Ongoing
Class II September 7, 2022 Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net… cGMP deviation: Product held outside of appropriate temperature storage conditions. Family Dollar Stores, Llc. Ongoing
Class II September 7, 2022 Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net… cGMP deviation: Product held outside of appropriate temperature storage conditions. Family Dollar Stores, Llc. Ongoing
Class III September 7, 2022 Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per… Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the… LNK International, Inc. Terminated
Class II September 7, 2022 Neomycin Sulfate Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA… CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in… Teva Pharmaceuticals USA Inc Terminated
Class III September 7, 2022 Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only,… Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point. Akorn, Inc Ongoing
Class II September 7, 2022 Triamcinolone Acetonide Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo,… CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. Padagis US LLC Terminated
Class II August 31, 2022 QP LAXATIVE BISACODYL 5 MG TABLET 50 CT SKU 902449 QP WOMEN LAXATIVE BISCODYL TABLET 25… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 NICORETTE GUM WHITE ICE MINT 4 MG 20 CT distributed to specific Family Dollar Stores… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 EXCEDRIN MIGRAINE CAPLET 24 CT distributed to specific Family Dollar Stores 04/30/2022… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 READY IN CASE MICON 7 DAY 1.59 OZ SKU 939212 READY IN CASE MICON 3 DAY COMBO PACK SKU… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 ZARBEES NTRL CHLD COUGH MUCUS GRP 4 FL OZ distributed to specific Family Dollar Stores… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 TN DICKINSON WITCH HAZEL 16 FL OZ distributed to specific Family Dollar Stores 04/30/2022… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 MIRALAX 8.3 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 ACNE FREE ADAPALENE GL ACN TRTMT 0.5 OZ SKU 2096518 ACNE FREE TRMINTR 10 SPOT TRTMT 1 OZ… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 Hydrogen Peroxide 16 fl. oz. and 32 oz. bottles distributed to specific Family Dollar… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mouthwash 1… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 MEDIC EYE DROPS MAX REDNESS SKU 998920 CLR EYS MX RDNS RLIF 0.5 FL OZ SKU 901844 SYSTANE… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 GC MILK OF MAGNESIA CHERRY 12 FL OZ SKU 915000 GC MILK OF MAGNESIA MINT 12 FL OZ SKU… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 Novelty Hand Sanitizer with Silicone Wrap SKU 998890 Novelty Hand Sanitizer Assorted SKU… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 PEPCID COMPLETE CHEWABLE TAB BERRY 8CT SKU 903365 PEPCID AC MAXIMUM STRENGTH TABLET 25 CT… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 AMBI NRSHNG DAILY FACIAL MSTURZER 1.7 OZ distributed to specific Family Dollar Stores… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 ZZZQUIL NIGHT PAIN BERRY 12 FL OZ distributed to specific Family Dollar Stores 04/30/2022… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 DR SCHOLLS CLR AWAY LIQ WART REMVR 20CT SKU 998384 DR SCHOLLS CALLUS REMOVER PADS 4CT SKU… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 VOLTAREN ARTHRITIS PAIN GEL 20G distributed to specific Family Dollar Stores 04/30/2022… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 AZO YEAST PLUS 20 CT distributed to specific Family Dollar Stores 04/30/2022 through… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 GUARDIAN ANTACID EX STRGTH TBLT FRT 96CT SKU 901379 GUARDIAN CHWABLE SMTHIES BRRY FSION… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 FS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ distributed to specific Family Dollar Stores… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 RIC STOOL SOFTENER SOFTGEL 100 CT SKU 917000 RIC STOOL SOFTNER 100 CT SKU 902493… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GELS 8 CT SKU… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 Dermasil Dry Skin Treatment 10 OZ SKU 2098068 Aveeno Daily Moisturizing Lotion 5 OZ SKU… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 ORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432 GOOD SENSE ORAL PAIN RELIEF 0.5OZ SKU… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 QP MOTION SICKNESS TABLET 8 CT distributed to specific Family Dollar Stores 04/30/2022… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 JOHNSONS BABY FIRST TOUCH GIFT SET 4PC distributed to specific Family Dollar Stores… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL OZ SKU 901880… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 READY IN CASE RUBBING ALCHL 50 PCT WNTRGRN 16 FLOZ distributed to specific Family Dollar… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 QP COLD MULTI SYMPTM DAY NITE CPLT 24 CT distributed to specific Family Dollar Stores… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 ZARBEES NTRLS BABY CGH MUCUS GRP 2 FL OZ distributed to specific Family Dollar Stores… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 GOOD SENSE HEMORRHOID OINTMENT 2 OZ SKU 910325 GOOD SENSE HEMORRHOIDAL WIPES 48 CT SKU… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 SWAN CALAMINE LOTION 6 FL OZ distributed to specific Family Dollar Stores 04/30/2022… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 BC ARTHRITIS PAIN FAST PAIN RELIEF 24CT SKU 999839 GOOD SENSE ARTHRITIS CAPLET 24 CT SKU… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 PREFERRED URINRY PN RLF MAX STRNGTH 12 CT distributed to specific Family Dollar Stores… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin Cream for oily skin 2 OZ SKU… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 SUAVE INV SLD PWDR 1.2 OZ SKU2004504 SUAVE AP INV SOLID SWEET PEA 1.2 OZ SKU 2004622 LADY… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 ALKA SELTZER EXTRA STRENGTH 24 CT distributed to specific Family Dollar Stores 04/30/2022… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 DULCOLAX 5 MG TABLET 25 CT distributed to specific Family Dollar Stores 04/30/2022… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 BENADRYL EXTRA STRENGTH CREAM 1 OZ distributed to specific Family Dollar Stores… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 READY IN CASE CTRZNE ALRGY ALL DY TBLT 5 CT SKU 900448 ZYRTEC CHILDRENS GRAPE 4 FL OZ SKU… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 DIAL MENS EUCALYPTUS AB BODY WASH 20 FLOZ SKU 2096030 distributed to specific Family… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing
Class II August 31, 2022 ST IVES BLKHD CLRNG GREEN TEA SCRUB 6 OZ SKU 2007787 AMBI EXFOLIATING WASH 5 OZ SKU… CGMP Deviations: product held outside appropriate storage temperature conditions. Family Dollar Stores, Llc. Ongoing