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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 September 6, 2023 oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Central Admixture Pharmacy Services, Inc. Terminated
Class II September 6, 2023 Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Central Admixture Pharmacy Services, Inc. Terminated
Class II September 6, 2023 CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL,… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Central Admixture Pharmacy Services, Inc. Terminated
Class II September 6, 2023 Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume =… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Central Admixture Pharmacy Services, Inc. Terminated
Class II September 6, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Central Admixture Pharmacy Services, Inc. Terminated
Class II September 6, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Central Admixture Pharmacy Services, Inc. Terminated
Class II September 6, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium**… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Central Admixture Pharmacy Services, Inc. Terminated
Class II September 6, 2023 PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only,… Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Central Admixture Pharmacy Services, Inc. Terminated
Class III September 6, 2023 Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by:… Cross contamination with other products Lundbeck LLC Completed
Class II September 6, 2023 DIANEAL LOW CALCIUM WITH DEXTROSE Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll… Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Baxter Healthcare Corporation Terminated
Class II September 6, 2023 DIANEAL LOW CALCIUM WITH DEXTROSE DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in… Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Baxter Healthcare Corporation Terminated
Class II August 30, 2023 Rufinamide Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by:… cGMP deviations: Batch was released prior to approval. Aurobindo Pharma USA Inc. Terminated
Class II August 30, 2023 All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar. CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually… Inmar Supply Chain Solutions, LLC Ongoing
Class III August 30, 2023 Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis… Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range. Imprimis NJOF, LLC Terminated
Class II August 30, 2023 Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2… CGMP Deviations Parker Laboratories, Inc. Terminated
Class II August 30, 2023 Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01),… CGMP Deviations Parker Laboratories, Inc. Terminated
Class II August 30, 2023 Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%),… CGMP Deviations Parker Laboratories, Inc. Terminated
Class II August 30, 2023 Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL… CGMP Deviations Parker Laboratories, Inc. Terminated
Class II August 30, 2023 Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01),… CGMP Deviations Parker Laboratories, Inc. Terminated
Class II August 30, 2023 NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding. Lack of Assurance of Sterility TMC Acquisitions LLC dba Tailor Made Compounding Terminated
Class II August 30, 2023 Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding. Lack of Assurance of Sterility TMC Acquisitions LLC dba Tailor Made Compounding Terminated
Class II August 30, 2023 Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%),… CGMP Deviations: Products not manufactured under current good manufacturing practices. Ecometics, Inc. Completed
Class II August 30, 2023 Rufinamide Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by:… cGMP deviations: Batch was released prior to approval. Aurobindo Pharma USA Inc. Terminated
Class II August 30, 2023 Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide… CGMP Deviations: Products not manufactured under current good manufacturing practices. Ecometics, Inc. Completed
Class II August 30, 2023 ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID… CGMP Deviations: Products not manufactured under current good manufacturing practices. Ecometics, Inc. Completed
Class II August 30, 2023 AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for… CGMP Deviations: Products not manufactured under current good manufacturing practices. Ecometics, Inc. Completed
Class II August 30, 2023 YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a)… CGMP Deviations: Products not manufactured under current good manufacturing practices. Ecometics, Inc. Completed
Class II August 30, 2023 Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0… CGMP Deviations: Products not manufactured under current good manufacturing practices. Ecometics, Inc. Completed
Class II August 30, 2023 activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted… CGMP Deviations: Products not manufactured under current good manufacturing practices. Ecometics, Inc. Completed
Class III August 30, 2023 bendamustine hydrochloride Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only,… Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial. Baxter Healthcare Corporation Completed
Class III August 30, 2023 Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg,… Subpotent: Out of Specification for Assay Test at the 3-month time point. Glenmark Pharmaceuticals Inc., USA Ongoing
Class II August 23, 2023 hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride… Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild… Colgate Palmolive Company Terminated
Class III August 23, 2023 Tobramycin Ophthalmic Solution Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic… Failed Impurities/Degradation Specifications ALEMBIC PHARMACEUTICALS, INC. Ongoing
Class III August 23, 2023 PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL… Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date Advanced Accelerator Applications USA, Inc. Terminated
Class III August 16, 2023 SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun… Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either… B. Braun Medical Inc. Terminated
Class III August 16, 2023 Dofetilide Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun… Out of Specification result observed in content uniformity testing SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II August 9, 2023 morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc.,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM, total… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10%, Total Volume = 250mL,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc.,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 50… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume =… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc.,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with **low calcium**… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride, (3 mg/mL), IV Bag, Rx only,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 heparin 2500 units added to 0.9% sodium chloride 250mL, CONCENTRATION = 10 units/mL, IV… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10%, total volume = 250mL,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc.,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume =… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 oxyTOCIN 30 units added to dextrose 5%/lactated ringers 500 mL, IV Bag, Rx Only, Central… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextrose, IV Bag,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Central… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium, IV Bag, total volume =… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 vancomycin 1.5 g/500 mL added to 0.9% sodium chloride, 3 mg/mL, IV Bag, Rx only, Cental… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 oxyTOCIN 20 units added to Lactated Ringer's 1000 mL, IV Bag, Rx only, Central Admixture… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 12 mEq K, Maintenance 4:1 in Ringer's Low Potassium, IV Bag, total… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium/low tromethamine, total… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume =… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc.,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, IV Bag, total… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, Central… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM, total… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only, Central… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 36 mEq K, Induction 4:1, High Potassium/Low tromethamine, IV Bag,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 units/mL, IV… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL, IV Bag, Rx only, Cental Admixture… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium**… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total volume =… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX Only,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 36 mEq K, Maintenance 8:1, low Potassium / low dextrose, IV Bag,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM and… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 5% with CALCIUM and… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only, Central… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume =… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 oxyTOCIN 10 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200mcg/mL, IV… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, Total Volume… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume =… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV Bag, total… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with low calcium and… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total volume = 250mL,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, IV Bag, Total Volume = 1818 mL, CRYSTALLOID INDUCTION, Rx only,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, Rx only,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx Only,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 heparin 2500 units/500mL added to 0.9% sodium chloride 5 units/mL, IV Bag, Rx only,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with CALCIUM, total… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 vancomycin 1.5 g/250 mL added to 0.9% sodium chloride, 6 mg/mL, IV Bag, Rx only, Cental… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume =… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, IV Bag, Total Volume = 572.64 mL,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with **low calcium**… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCIUM and… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only,… Lack of assurance of sterility: Lack of validation data for sanitization cycles Central Admixture Pharmacy Services Inc Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 mL, Rx only,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with **low calcium**… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only,… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This drug was… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class I August 9, 2023 Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03… Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive… Lupin Pharmaceuticals Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM, total… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, total volume =… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, IV Bag, total volume =… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central… Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Central Admixture Pharmacy Services, Inc. Terminated
Class II August 9, 2023 Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx… CGMP deviation: product released prior to supplier approval. The Ritedose Corporation Completed
Class II August 2, 2023 Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded… Lack of Assurance of Sterility New Vitalis Pharmacy LLC dba New Vitalis Pharmacy Ongoing
Class II August 2, 2023 Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0… CGMP Deviations: use of non-food grade lubricant in mixing vessel. Kramer Laboratories, Inc. Terminated
Class II August 2, 2023 FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag,… cGMP deviations: due to shipment of rejected units. SCA Pharmaceuticals Terminated
Class II August 2, 2023 Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant… CGMP Deviations: use of non-food grade lubricant in mixing vessel. Kramer Laboratories, Inc. Terminated
Class II August 2, 2023 METHYLPHENIDATE HYDROCHLORIDE Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle,… Presence of Foreign Substance: Metal embedded in a tablet. SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II August 2, 2023 Diclofenac Sodium Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only,… Defective Delivery System ALEMBIC PHARMACEUTICALS, INC. Ongoing
Class II August 2, 2023 Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous… Lack of Assurance of Sterility Sagent Pharmaceuticals Ongoing
Class II August 2, 2023 Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a)… Lack of Assurance of Sterility Sagent Pharmaceuticals Ongoing
Class II August 2, 2023 Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT… Lack of Assurance of Sterility Sagent Pharmaceuticals Ongoing
Class II July 26, 2023 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II July 26, 2023 Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II July 26, 2023 ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding… CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. New England Life Care, Inc. dba Advanced Compounding Solutions Terminated
Class II July 26, 2023 PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total… CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. New England Life Care, Inc. dba Advanced Compounding Solutions Terminated
Class II July 26, 2023 Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total… CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. New England Life Care, Inc. dba Advanced Compounding Solutions Terminated
Class II July 26, 2023 Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II July 26, 2023 Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II July 26, 2023 SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced… CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. New England Life Care, Inc. dba Advanced Compounding Solutions Terminated
Class II July 26, 2023 Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single… Lack of Assurance of Sterility SterRx, LLC Terminated
Class II July 26, 2023 Famotidine Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark… Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed… Glenmark Therapeutics, Inc. Terminated
Class II July 26, 2023 Fingolimod Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem… Failed Dissolution Specifications Ascend Laboratories, LLC Ongoing
Class II July 26, 2023 Tizanidine Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's… Failed dissolution specification: Out of specification results observed in 24-month long term stability testing. Dr Reddy's Laboratories Limited Ongoing
Class III July 26, 2023 loteprednol etabonate Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a… Superpotent Drug: Out of Specification (OOS) results observed for unit dose content. SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II July 19, 2023 bivalirudin Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord… Presence of Particulate Matter: Particulate matter identified as fiber. Accord Healthcare, Inc. Terminated
Class II July 19, 2023 basic care allergy Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC… Failed Impurities/Degradation Specifications L. Perrigo Company Terminated
Class II July 19, 2023 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10… CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured… Global Pharma Healthcare Private Limited Ongoing
Class I July 19, 2023 Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2… Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Global Pharma Healthcare Private Limited Ongoing
Class I July 19, 2023 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10… Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Global Pharma Healthcare Private Limited Ongoing
Class II July 19, 2023 Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2… CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured… Global Pharma Healthcare Private Limited Ongoing
Class II July 19, 2023 SODIUM CHLORIDE 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun… Lack of assurance of sterility: bags have the potential to leak. B. Braun Medical Inc. Terminated
Class II July 19, 2023 Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons,… Failed Impurities/Degradation Specifications L. Perrigo Company Terminated
Class II July 19, 2023 allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons… Failed Impurities/Degradation Specifications L. Perrigo Company Terminated
Class II July 19, 2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed… Failed Impurities/Degradation Specifications L. Perrigo Company Terminated
Class II July 19, 2023 Fexofenadine Hydrochloride Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo,… Failed Impurities/Degradation Specifications L. Perrigo Company Terminated
Class II July 19, 2023 Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical… CGMP Deviation: impurities exceed allowable limits. Tenn South Distillery LLC dba Big Machine Distillery Ongoing
Class II July 19, 2023 Tiagabine Hydrochloride Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical… Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II July 19, 2023 allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count… Failed Impurities/Degradation Specifications L. Perrigo Company Terminated
Class II July 19, 2023 aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For:… Failed Impurities/Degradation Specifications L. Perrigo Company Terminated
Class II July 19, 2023 ATROPINE SULFATE Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose… Presence of Particulate Matter: Particulate matter identified as fiber. Accord Healthcare, Inc. Terminated
Class II July 19, 2023 Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons,… Failed Impurities/Degradation Specifications L. Perrigo Company Terminated
Class II July 19, 2023 allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count… Failed Impurities/Degradation Specifications L. Perrigo Company Terminated
Class III July 19, 2023 Amlodipine Besylate Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for:… Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study. Lupin Pharmaceuticals Inc. Terminated
Class II July 19, 2023 Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC… Failed Impurities/Degradation Specifications L. Perrigo Company Terminated
Class II July 19, 2023 Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene… CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. K.C. Pharmaceuticals, Inc Ongoing
Class II July 19, 2023 Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count… Failed Impurities/Degradation Specifications L. Perrigo Company Terminated
Class II July 19, 2023 Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL);… CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. K.C. Pharmaceuticals, Inc Ongoing
Class II July 19, 2023 Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons,… Failed Impurities/Degradation Specifications L. Perrigo Company Terminated
Class II July 19, 2023 CareOne Allergy Relief Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed… Failed Impurities/Degradation Specifications L. Perrigo Company Terminated
Class I July 19, 2023 Albuterol Sulfate Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g… Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat… Cipla USA, Inc. Terminated
Class II July 19, 2023 Sunitinib Malate Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva… Failed Moisture Limits: Water (moisture) content above the approved product specifications. Teva Pharmaceuticals USA Inc Terminated
Class III July 19, 2023 PANCREAZE PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only,… Failed Stability Specifications Vivus, Inc. Ongoing
Class II July 12, 2023 Tizanidine Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2),… Failed Stability Specifications Preferred Pharmaceuticals, Inc. Ongoing
Class II July 12, 2023 Tizanidine Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per… Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories,… Amerisource Health Services LLC Terminated
Class II July 12, 2023 Losartan Potassium Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only,… Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. Strides Pharma Inc. Terminated
Class II July 5, 2023 Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun… Subpotent drug SUN PHARMACEUTICAL INDUSTRIES INC Terminated
Class II July 5, 2023 Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal… cGMP deviations: potential for Microbial Contamination of Non-Sterile Products Ferring Pharmaceuticals Inc Terminated
Class II July 5, 2023 StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife,… cGMP deviations Homeocare Laboratories, Inc. Terminated
Class II July 5, 2023 Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY… cGMP deviations Homeocare Laboratories, Inc. Terminated
Class II July 5, 2023 Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by… cGMP deviations Homeocare Laboratories, Inc. Terminated
Class II July 5, 2023 StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc.,… cGMP deviations Homeocare Laboratories, Inc. Terminated
Class II July 5, 2023 DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE… cGMP deviations Homeocare Laboratories, Inc. Terminated
Class II July 5, 2023 Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by… cGMP deviations Homeocare Laboratories, Inc. Terminated
Class II July 5, 2023 Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For:… cGMP deviations Homeocare Laboratories, Inc. Terminated
Class II July 5, 2023 Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only,… Packaging defect: blister packaging inadequately sealed. The Harvard Drug Group Terminated
Class II July 5, 2023 StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by:… cGMP deviations Homeocare Laboratories, Inc. Terminated
Class II July 5, 2023 SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99 cGMP deviations Homeocare Laboratories, Inc. Terminated
Class II July 5, 2023 StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by:… cGMP deviations Homeocare Laboratories, Inc. Terminated
Class II July 5, 2023 StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by:… cGMP deviations Homeocare Laboratories, Inc. Terminated
Class III June 28, 2023 GLYCOPYRROLATE Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo… Failed Impurities/Degradation Specifications Aurolife Pharma, LLC Terminated
Class I June 28, 2023 ziprasidone ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By:… Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain… The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Terminated
Class II June 21, 2023 Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution,… CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products. Jarman's Midwest Cleaning Systems, Inc. Terminated
Class I June 21, 2023 SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE… Chemical Contamination: FDA testing found Presence of methanol Jarman's Midwest Cleaning Systems, Inc. Terminated
Class I June 21, 2023 Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume:… Chemical Contamination: FDA testing found Presence of methanol Jarman's Midwest Cleaning Systems, Inc. Terminated
Class III June 21, 2023 Tranexamic Acid Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only,… Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. Amring Pharmaceuticals Inc Terminated
Class II June 21, 2023 Extended Phenytoin Sodium Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle,… Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification) Amneal Pharmaceuticals of New York, LLC Terminated
Class III June 21, 2023 Tranexamic Acid Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured… Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. AVKARE LLC Ongoing
Class II June 14, 2023 ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial,… Mislabeling: preservative free product labeled as preserved. Empower Clinic Services LLC dba Empower Pharmacy Completed
Class III June 14, 2023 Glycopyrrolate GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC,… Labeling: Label Mix-up HF Acquisition Co LLC Terminated
Class II June 14, 2023 Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for… CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity,… Viatris Inc Terminated