Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on April 12, 2024 and include a total of 16143 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0055-2024 | 10-02-2023 | Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 2181 droppers | Class II | Completed |
| D-0064-2024 | 10-02-2023 | Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 860 syringes | Class II | Completed |
| D-0050-2024 | 10-02-2023 | Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 2862 Syringes | Class II | Completed |
| D-0054-2024 | 10-02-2023 | Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 881 pre-filled syringes | Class II | Completed |
| D-0057-2024 | 10-02-2023 | Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150. | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC / 4972 syringes | Class II | Completed |
| D-0069-2024 | 09-29-2023 | Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA | Microbial contamination of Non-Sterile Products | Biomic Sciences, LLC dba ION Intelligence of Nature / | Class II | Ongoing |
| D-0067-2024 | 09-29-2023 | ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA | Microbial contamination of Non-Sterile Products | Biomic Sciences, LLC dba ION Intelligence of Nature / | Class I | Ongoing |
| D-0068-2024 | 09-29-2023 | ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA | Microbial contamination of Non-Sterile Products | Biomic Sciences, LLC dba ION Intelligence of Nature / | Class II | Ongoing |
| D-0081-2024 | 09-28-2023 | Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01 Package NDCs: 45802-396-01; 45802-396-02 | Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process. | Padagis US LLC / 10,512 cartons | Class II | Ongoing |
| D-0041-2024 | 09-28-2023 | Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular, epidural, or intrathecal use, Mfd. in India for Auromedics Pharma LLC., E Windsor, NJ, 08520, NDC 55150-385-01. Package NDCs: 55150-384-01; 55150-385-01 | Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial. | Eugia US LLC / 1,626 vials | Class II | Ongoing |
| D-0042-2024 | 09-25-2023 | BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04 Package NDCs: 75788-115-04 | Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound). | Scynexis, Inc. / 17,376 | Class I | Ongoing |
| D-0066-2024 | 09-22-2023 | Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25 Package NDCs: 0054-4550-25; 0054-4550-15; 0054-8550-25 | Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring. | West-Ward Columbus Inc / 2,673 cartons | Class III | Ongoing |
| D-0038-2024 | 09-21-2023 | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 Package NDCs: 68382-255-06; 68382-255-14; 68382-255-16; 68382-255-01; 68382-255-05; 68382-255-30; 68382-255-77; 68382-256-14; 68382-256-01; 68382-256-16; 68382-256-05; 68382-256-30; 68382-256-77; 68382-256-06; 68382-257-14; 68382-257-01; 68382-257-16; 68382-257-05; 68382-257-30; 68382-257-77; 68382-257-06 | Failed Dissolution Specifications | Zydus Pharmaceuticals (USA) Inc / 7,248 bottles | Class II | Ongoing |
| D-0043-2024 | 09-20-2023 | MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05 | Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim. | Imprimis NJOF, LLC / 6,228 bags + 15,360 boxes | Class III | Ongoing |
| D-0049-2024 | 09-20-2023 | Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01. Package NDCs: 10702-013-01; 10702-014-01 | Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles. | KVK-Tech, Inc. / 1488 bottles | Class I | Ongoing |
| D-0047-2024 | 09-15-2023 | Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16 Package NDCs: 66689-305-16 | Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus. | VistaPharm LLC / 180 bottles | Class I | Completed |
| D-1178-2023 | 09-12-2023 | Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526. Package NDCs: 62935-753-75; 62935-754-74; 62935-755-75; 62935-223-05; 62935-221-04; 62935-224-05; 62935-303-30; 62935-305-29; 62935-304-30; 62935-453-45; 62935-454-44; 62935-455-45 | Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product. | Tolmar, Inc. / 2990 cartons | Class III | Ongoing |
| D-0046-2024 | 09-08-2023 | TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, NJ 08628 | Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis | Church & Dwight Inc / 5,316 bottles | Class I | Ongoing |
| D-1174-2023 | 09-08-2023 | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22. Package NDCs: 0078-0240-61; 0078-0240-15; 0078-0241-61; 0078-0241-15; 0078-0109-61; 0078-0109-01; 0078-0110-22 | Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals. | Novartis Pharmaceuticals Corp. / 1272 bottles | Class I | Ongoing |
| D-1172-2023 | 09-07-2023 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96 Package NDCs: 47335-506-96; 47335-507-97 | Subpotent: Out of Specification result observed for low assay | SUN PHARMACEUTICAL INDUSTRIES INC / 69,707 cartons | Class III | Terminated |
| D-1148-2023 | 09-05-2023 | Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511. Package NDCs: 71839-122-25; 71839-122-10; 71839-122-01 | Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials. | BE PHARMACEUTICALS AG / 41,148 vials | Class II | Ongoing |
| D-1157-2023 | 09-01-2023 | TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-417-19. Package NDCs: 17312-417-19; 17312-417-99 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,000 units | Class II | Ongoing |
| D-1160-2023 | 09-01-2023 | MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38. Package NDCs: 0904-6488-38 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 282,564 units | Class II | Ongoing |
| D-1167-2023 | 09-01-2023 | octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15. Package NDCs: 57483-610-15 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 30,490 units | Class II | Ongoing |
| D-0039-2024 | 09-01-2023 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11 Package NDCs: 68084-447-11; 68084-447-01 | Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point. | Amerisource Health Services LLC / 3,344 cartons | Class III | Ongoing |
| D-1161-2023 | 09-01-2023 | TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-013-15. Package NDCs: 17312-013-15; 17312-013-99 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 293,400 units | Class II | Ongoing |
| D-1151-2023 | 09-01-2023 | TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-027-15. Package NDCs: 17312-027-15 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,747 units | Class II | Ongoing |
| D-1154-2023 | 09-01-2023 | TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-002-11. Package NDCs: 17312-002-11 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 5,509 | Class II | Ongoing |
| D-1163-2023 | 09-01-2023 | TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-058-15. Package NDCs: 17312-058-15; 17312-058-99 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,868 units | Class II | Ongoing |
| D-1158-2023 | 09-01-2023 | TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-165-13. Package NDCs: 17312-165-13 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 16,500 units | Class II | Ongoing |
| D-1166-2023 | 09-01-2023 | TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-099-15. Package NDCs: 17312-099-15 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,819 | Class II | Ongoing |
| D-1156-2023 | 09-01-2023 | TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-096-19. Package NDCs: 17312-096-19; 17312-096-99 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 83,898 units | Class II | Ongoing |
| D-1152-2023 | 09-01-2023 | TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-032-15. Package NDCs: 17312-032-15; 17312-032-99 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,747 | Class II | Ongoing |
| D-1159-2023 | 09-01-2023 | TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-098-15. Package NDCs: 17312-098-15 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 18,171 units | Class II | Ongoing |
| D-1164-2023 | 09-01-2023 | TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-095-19. Package NDCs: 17312-095-19; 17312-095-99 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 196,442 units | Class II | Ongoing |
| D-1153-2023 | 09-01-2023 | TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-097-19. Package NDCs: 17312-097-19; 17312-097-99 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,810 units | Class II | Ongoing |
| D-1155-2023 | 09-01-2023 | TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC:17312-178-15. Package NDCs: 17312-178-15; 17312-178-99 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 196,111 units | Class II | Ongoing |
| D-1165-2023 | 09-01-2023 | TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13. Package NDCs: 17312-014-13 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 180,315 units | Class II | Ongoing |
| D-1162-2023 | 09-01-2023 | TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-094-19. Package NDCs: 17312-094-19; 17312-094-99 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,873 | Class II | Ongoing |
| D-1149-2023 | 08-30-2023 | Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16 Package NDCs: 66689-305-16 | Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results | VistaPharm LLC / 14,400 bottles | Class II | Ongoing |
| D-1179-2023 | 08-29-2023 | Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in case of 6 jars per case, Distributed by RB Health (US), Parsippany, NJ 07054, NDC 63824-431-90 Package NDCs: 63824-431-90 | Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging. | RB Health (US) LLC / 6,072 cases/36,426 individual selling units | Class III | Ongoing |
| D-0037-2024 | 08-26-2023 | Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001111. | Non-Sterility | Dr. Berne's Whole Health Products / | Class I | Ongoing |
| D-0036-2024 | 08-26-2023 | Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001111. | CGMP Deviations | Dr. Berne's Whole Health Products / 3833 bottles | Class II | Ongoing |
| D-0035-2024 | 08-26-2023 | Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], Certified Organic by Organic Certifiers. | CGMP Deviations | Dr. Berne's Whole Health Products / 1744 bottles | Class II | Ongoing |
| D-0034-2024 | 08-26-2023 | Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected]. | CGMP Deviations | Dr. Berne's Whole Health Products / 795 bottles | Class II | Ongoing |
| D-0033-2024 | 08-26-2023 | Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001036 | CGMP Deviations | Dr. Berne's Whole Health Products / 6060 bottles | Class II | Ongoing |
| D-1180-2023 | 08-25-2023 | WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5 | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug. | Hua Da Trading, Inc. dba Wefun Inc. / 300 cartons | Class I | Ongoing |
| D-1170-2023 | 08-25-2023 | Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01 | Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg. | Marlex Pharmaceuticals, Inc. / 94/100 count bottles | Class II | Completed |
| D-1169-2023 | 08-25-2023 | Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01 | Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg. | Marlex Pharmaceuticals, Inc. / 94/100 count bottles | Class I | Completed |
| D-1168-2023 | 08-25-2023 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case). Package NDCs: 54365-400-31 | Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides. | CareFusion 213, LLC / 398,160 cartons | Class II | Ongoing |
| D-0048-2024 | 08-24-2023 | Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01 Package NDCs: 0338-0063-01; 0338-0067-01 | CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake. | Baxter Healthcare Corporation / 472 vials | Class II | Completed |
| D-1139-2023 | 08-23-2023 | Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, NDC# 71428-003-60 Package NDCs: 71428-003-60; 71428-003-30 | Defective Container: slow leakage under the cap | Contract Pharmaceuticals Limited Canada / 11,350 bottles | Class III | Ongoing |
| D-1177-2023 | 08-22-2023 | Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only, Manufactured by SOFIE Co dba SOFIE, Dulles, VA 20166 for Life Molecular Imagining Ltd., NDC 54828-001-50 Package NDCs: 54828-001-30; 54828-001-50 | Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT). | Sofie Co dba Sofie / 6 patient doses | Class II | Terminated |
| D-1176-2023 | 08-18-2023 | Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002 | Subpotent Drug: Product does not contain SPF that is declared on the label. | HUMANRACE / 2942 units | Class II | Ongoing |
| D-1175-2023 | 08-18-2023 | Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01 | Subpotent Drug: Product does not contain SPF that is declared on the label. | HUMANRACE / 5046 units | Class II | Ongoing |
| D-1142-2023 | 08-17-2023 | Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65 Package NDCs: 67386-211-65 | Cross contamination with other products | Lundbeck LLC / 10,543 cartons | Class III | Completed |
| D-1119-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 136 bags | Class II | Ongoing |
| D-1122-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 108 bags | Class II | Ongoing |
| D-1136-2023 | 08-17-2023 | vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 477 bags | Class II | Ongoing |
| D-1132-2023 | 08-17-2023 | oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 1,996 bags. | Class II | Ongoing |
| D-1134-2023 | 08-17-2023 | oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 298 bags | Class II | Ongoing |
| D-1127-2023 | 08-17-2023 | PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 292 bags | Class II | Ongoing |
| D-1112-2023 | 08-17-2023 | Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 786 Bags | Class II | Ongoing |
| D-1110-2023 | 08-17-2023 | CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 84 bags | Class II | Ongoing |
| D-1111-2023 | 08-17-2023 | Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 100 bags | Class II | Ongoing |
| D-1117-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 104 bags | Class II | Ongoing |
| D-1126-2023 | 08-17-2023 | PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 297 bags | Class II | Ongoing |
| D-1123-2023 | 08-17-2023 | CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 16 bags | Class II | Ongoing |
| D-1107-2023 | 08-17-2023 | CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 304 bags | Class II | Ongoing |
| D-1130-2023 | 08-17-2023 | EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 292 bags. | Class II | Ongoing |
| D-1109-2023 | 08-17-2023 | CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 84 bags | Class II | Ongoing |
| D-1115-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 40 bags | Class II | Ongoing |
| D-1133-2023 | 08-17-2023 | oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 2643 bags | Class II | Ongoing |
| D-1137-2023 | 08-17-2023 | dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 235 bags | Class II | Ongoing |
| D-1129-2023 | 08-17-2023 | EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 340 bags | Class II | Ongoing |
| D-1118-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 140 bags | Class II | Ongoing |
| D-1113-2023 | 08-17-2023 | rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 3519 Syringes | Class II | Ongoing |
| D-1135-2023 | 08-17-2023 | heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 577 bags | Class II | Ongoing |
| D-1114-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 84 bags | Class II | Ongoing |
| D-1138-2023 | 08-17-2023 | dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 703 bags. | Class II | Ongoing |
| D-1125-2023 | 08-17-2023 | PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 586 bags | Class II | Ongoing |
| D-1121-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 92 bags | Class II | Ongoing |
| D-1131-2023 | 08-17-2023 | EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 554 bags | Class II | Ongoing |
| D-1124-2023 | 08-17-2023 | PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 4100 syringes | Class II | Ongoing |
| D-1128-2023 | 08-17-2023 | PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 340 bags | Class II | Ongoing |
| D-1116-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 200 bags | Class II | Ongoing |
| D-1120-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 132 bags | Class II | Ongoing |
| D-1108-2023 | 08-17-2023 | CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 184 | Class II | Ongoing |
| D-1143-2023 | 08-16-2023 | Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03 Package NDCs: 72426-818-03; 72426-818-09; 72426-818-99 | Failed dissolution specifications: below specification results at stability 12-month | Esperion / 45,240 bottles | Class III | Ongoing |
| D-1105-2023 | 08-15-2023 | Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding. | Lack of Assurance of Sterility | TMC Acquisitions LLC dba Tailor Made Compounding / 9 vials | Class II | Completed |
| D-1106-2023 | 08-15-2023 | NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding. | Lack of Assurance of Sterility | TMC Acquisitions LLC dba Tailor Made Compounding / 99 vials | Class II | Completed |
| D-1104-2023 | 08-14-2023 | 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 hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling. | Inmar Supply Chain Solutions, LLC / Unknown | Class II | Ongoing |
| D-1095-2023 | 08-14-2023 | Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01 Package NDCs: 68462-329-01; 68462-329-10; 68462-295-01; 68462-295-10; 68462-295-90; 68462-296-01; 68462-296-10; 68462-296-90; 68462-294-01; 68462-294-10; 68462-294-90 | Subpotent: Out of Specification for Assay Test at the 3-month time point. | Glenmark Pharmaceuticals Inc., USA / 1,200 bottles | Class III | Ongoing |
| D-1103-2023 | 08-14-2023 | Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01. Package NDCs: 10019-079-01 | Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial. | Baxter Healthcare Corporation / 13,502 vials | Class III | Completed |
| D-1144-2023 | 08-14-2023 | Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10 Package NDCs: 72485-501-01; 72485-501-10; 72485-502-01; 72485-502-10; 72485-503-01 | Failed Impurities/Degradation Specifications | Caplin Steriles Limited / 19, 820 vials | Class III | Ongoing |
| D-1147-2023 | 08-11-2023 | Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478 Package NDCs: 50268-195-60 | Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste | AVKARE LLC / 35,184 cartons | Class II | Completed |
| D-1141-2023 | 08-11-2023 | Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07 Package NDCs: 0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0426-55; 0941-0427-52; 0941-0427-53; 0941-0427-55; 0941-0429-52; 0941-0429-53; 0941-0429-55; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0424-55; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0430-55; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0433-55; 0941-0484-01; 0941-0487-01; 0941-0490-01 | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. | Baxter Healthcare Corporation / 22,112 bags | Class II | Ongoing |
| D-1140-2023 | 08-11-2023 | DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Package NDCs: 0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0426-55; 0941-0427-52; 0941-0427-53; 0941-0427-55; 0941-0429-52; 0941-0429-53; 0941-0429-55; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0424-55; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0430-55; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0433-55; 0941-0484-01; 0941-0487-01; 0941-0490-01 | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. | Baxter Healthcare Corporation / a) 44,520; b) 60,762; c) 483,912 | Class II | Ongoing |
| D-1146-2023 | 08-11-2023 | Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478 Package NDCs: 42291-741-51 | Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste | AVKARE LLC / 35,184 tubes | Class II | Completed |
| D-1084-2023 | 08-10-2023 | hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distributed by Hello Products LLC, Montclair, NJ 07042, UPC 8 19156 02026 4 (carton), 12-count case GTIN: 20819156020268; strawberry tubes also sold in Strawberry 3-pack overwrap UPC 8 19156 02349 4, UPC 10819156023491 case; in the variety 3-pack of Strawberry + Unicorn + Grape UPC 8 19156 02332 6, UPC 10819156023323 case; and in a 24-count Toothpaste Floorstand, UPC 819156020684 (case). | Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste. | Colgate Palmolive Company / 182,046 tubes | Class II | Terminated |