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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0139-2023 | 10-13-2022 | Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31 | CGMP Deviations: | Akorn, Inc. / 36,455 cartons | Class II | Ongoing |
| D-0154-2023 | 10-13-2022 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15 | CGMP Deviations: | Akorn, Inc. / 23,026 bottles | Class II | Ongoing |
| D-0150-2023 | 10-13-2022 | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05 | CGMP Deviations: | Akorn, Inc. / 163,996 bottles | Class II | Ongoing |
| D-0153-2023 | 10-13-2022 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031 NDC: 17478-263-12 | CGMP Deviations: | Akorn, Inc. / 267,678 bottles | Class II | Ongoing |
| D-0141-2023 | 10-13-2022 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-209-11; (b) 3 mL dropper bottle, NDC 17478-209-19; (c) 5 mL dropper bottle, NDC 17478-209-10; Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. | CGMP Deviations: | Akorn, Inc. / 314,543 10ml,3ml, 5ml bottles | Class II | Ongoing |
| D-0157-2023 | 10-13-2022 | Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10 | CGMP Deviations: | Akorn, Inc. / 2,095,068 bottles | Class II | Ongoing |
| D-0151-2023 | 10-13-2022 | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05 | CGMP Deviations: | Akorn, Inc. / 121,176 bottles | Class II | Ongoing |
| D-0143-2023 | 10-13-2022 | Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. | CGMP Deviations: | Akorn, Inc. / 2,369,258 tubes | Class II | Ongoing |
| D-0135-2023 | 10-13-2022 | Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10 | CGMP Deviations: | Akorn, Inc. / 6,273 bottles | Class II | Ongoing |
| D-0137-2023 | 10-13-2022 | Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11 | CGMP Deviations: | Akorn, Inc. / 188,550 bottles | Class II | Ongoing |
| D-0152-2023 | 10-13-2022 | PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12 | CGMP Deviations: | Akorn, Inc. / 51,601 bottles | Class II | Ongoing |
| D-0156-2023 | 10-13-2022 | Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. | CGMP Deviations: | Akorn, Inc. / 1,310,324 bottles | Class II | Ongoing |
| D-0147-2023 | 10-13-2022 | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05 | CGMP Deviations: | Akorn, Inc. / 31,073 bottles | Class II | Ongoing |
| D-0134-2023 | 10-13-2022 | Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12 | CGMP Deviations: | Akorn, Inc. / 967,075 bottles | Class II | Ongoing |
| D-0132-2023 | 10-13-2022 | AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35 | CGMP Deviations: | Akorn, Inc. / 36,025 tubes | Class II | Ongoing |
| D-0138-2023 | 10-13-2022 | ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35 | CGMP Deviations: | Akorn, Inc. / 1,109,600 tubes | Class II | Ongoing |
| D-0146-2023 | 10-13-2022 | Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05 | CGMP Deviations: | Akorn, Inc. / 65,006 bottles | Class II | Ongoing |
| D-0145-2023 | 10-13-2022 | Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35 | CGMP Deviations: | Akorn, Inc. / 2,082 tubes | Class II | Ongoing |
| D-0149-2023 | 10-13-2022 | Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12 | CGMP Deviations: | Akorn, Inc. / 173,928 bottles | Class II | Ongoing |
| D-0155-2023 | 10-13-2022 | Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35 | CGMP Deviations: | Akorn, Inc. / 524,506 tubes | Class II | Ongoing |
| D-0133-2023 | 10-13-2022 | Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35 | CGMP Deviations: | Akorn, Inc. / 1,164,171 tubes | Class II | Ongoing |
| D-0136-2023 | 10-13-2022 | Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25 | CGMP Deviations: | Akorn, Inc. / 1,584 bottles | Class II | Ongoing |
| D-0144-2023 | 10-13-2022 | Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19 | CGMP Deviations: | Akorn, Inc. / 2,563 bottles | Class II | Ongoing |
| D-0158-2023 | 10-13-2022 | Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05 | CGMP Deviations: | Akorn, Inc. / 91,692 bottles | Class II | Ongoing |
| D-0140-2023 | 10-13-2022 | GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12 | CGMP Deviations: | Akorn, Inc. / 196,254 bottles | Class II | Ongoing |
| D-0142-2023 | 10-13-2022 | Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10 | CGMP Deviations: | Akorn, Inc. / 3108 bottles | Class II | Ongoing |
| D-0148-2023 | 10-13-2022 | Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05 | CGMP Deviations: | Akorn, Inc. / 1,752 bottles | Class II | Ongoing |
| D-0014-2023 | 10-11-2022 | NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com Package NDCs: 0363-6171-09 | Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg | LNK International, Inc. / 66,384 boxes of twenty tablets each | Class III | Terminated |
| D-0015-2023 | 10-11-2022 | 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10 Package NDCs: 49230-300-10 | Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution. | Fresenius Medical Care Holdings, Inc. / 16,006 cases of twelve bags each | Class II | Ongoing |
| D-0058-2023 | 10-07-2022 | Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton). Package NDCs: 67457-239-00; 67457-239-01; 67457-245-00; 67457-245-01; 67457-246-00; 67457-246-01 | Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe. | Viatris Inc / 22400 syringes | Class I | Terminated |
| D-0030-2023 | 10-07-2022 | CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 12 syringes | Class II | Ongoing |
| D-0056-2023 | 10-07-2022 | VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 12 syringes | Class II | Ongoing |
| D-0032-2023 | 10-07-2022 | CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 67 bottles | Class II | Ongoing |
| D-0048-2023 | 10-07-2022 | PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 5 vials | Class II | Ongoing |
| D-0041-2023 | 10-07-2022 | PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 2 vials | Class II | Ongoing |
| D-0035-2023 | 10-07-2022 | LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 389 syringes | Class II | Ongoing |
| D-0042-2023 | 10-07-2022 | PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 56 vials | Class II | Ongoing |
| D-0047-2023 | 10-07-2022 | PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 28 vials | Class II | Ongoing |
| D-0026-2023 | 10-07-2022 | ACETYLCYSTEINE OPTH 10% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 droptainer | Class II | Ongoing |
| D-0043-2023 | 10-07-2022 | PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 150MG/10MG/100MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vial | Class II | Ongoing |
| D-0052-2023 | 10-07-2022 | PROSTAGLANDIN E1 INJECTION SOLUTION 500MCG/ML SOLUTION, 1 ML vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 50 vials | Class II | Ongoing |
| D-0046-2023 | 10-07-2022 | PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 242 vials | Class II | Ongoing |
| D-0038-2023 | 10-07-2022 | METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 514 vials | Class II | Ongoing |
| D-0050-2023 | 10-07-2022 | PHENTOLAMINE 10MG/ML INJECTION, 10MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 10 vials | Class II | Ongoing |
| D-0051-2023 | 10-07-2022 | PRED ACETATE / GATIFLOXACIN 1% / 0.5% SUSP, 10 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 378 droptainers | Class II | Ongoing |
| D-0037-2023 | 10-07-2022 | MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 40 vials | Class II | Ongoing |
| D-0039-2023 | 10-07-2022 | MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 185 syringes | Class II | Ongoing |
| D-0029-2023 | 10-07-2022 | BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 86 vials | Class II | Ongoing |
| D-0055-2023 | 10-07-2022 | TALC, STERILE POWDER, 5 GM vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vial | Class II | Ongoing |
| D-0034-2023 | 10-07-2022 | LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 3 vials | Class II | Ongoing |
| D-0054-2023 | 10-07-2022 | SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 45 droptainers | Class II | Ongoing |
| D-0027-2023 | 10-07-2022 | ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 2 droptainers | Class II | Ongoing |
| D-0049-2023 | 10-07-2022 | PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150MG/5MG/10MCG/VIAL SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vial | Class II | Ongoing |
| D-0033-2023 | 10-07-2022 | GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 droptainer | Class II | Ongoing |
| D-0044-2023 | 10-07-2022 | PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 75MG/2.5MG/50MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 vial | Class II | Ongoing |
| D-0040-2023 | 10-07-2022 | MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 106 syringes | Class II | Ongoing |
| D-0031-2023 | 10-07-2022 | CEFUROXIME INTRAVITREAL SYR 1MG/0.1ML Solution in 1 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 460 syringes | Class II | Ongoing |
| D-0057-2023 | 10-07-2022 | VORICONAZOLE OPTH SOLUTION 2% STERILE SOLN, 10 ML droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 1 droptainer | Class II | Ongoing |
| D-0053-2023 | 10-07-2022 | SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 800.5 mL in unit dose vials | Class II | Ongoing |
| D-0036-2023 | 10-07-2022 | LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 7 syringes | Class II | Ongoing |
| D-0028-2023 | 10-07-2022 | AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 168 droptainers | Class II | Ongoing |
| D-0045-2023 | 10-07-2022 | PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Pharmacy Plus, Inc. dba Vital Care Compounder / 2 vials | Class II | Ongoing |
| D-0166-2023 | 10-06-2022 | SIREtizer Hand Sanitizer (Ethyl Alcohol) 80%, packaged in a) 3.38 oz (100 mL), b) 10 oz (295 ml), UPC 8 60003 85882 0, and c) 16.9 oz (500 ml), UPC 8 60003 85880 6 bottles, Southwest Iowa Renewable Energy, 10868 189th Street, Council Bluffs, IA 51503; Bottled by Southwest 6th Beverages, LLC, Lincoln, NE 68522 and Bottled by South Tenth Development, LLC, Lincoln, NE 68522. | CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent. | Southwest Iowa Renewable Energy LLC / a) 3,008 bottles; b) 120 bottles; c) 9,576 bottles | Class II | Ongoing |
| D-0011-2023 | 10-06-2022 | Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA. | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). | Golden State Medical Supply Inc. / N/A | Class II | Terminated |
| D-0012-2023 | 10-06-2022 | Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC 51407-322-30 | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). | Golden State Medical Supply Inc. / N/A | Class II | Terminated |
| D-0021-2023 | 10-05-2022 | Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90 Package NDCs: 65862-161-90; 65862-162-30; 65862-162-90; 65862-163-90 | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. | Aurobindo Pharma USA Inc. / 9504 bottles | Class II | Completed |
| D-0023-2023 | 10-04-2022 | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1. | Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration | Exela Pharma Sciences LLC / 148,920 | Class I | Terminated |
| D-0022-2023 | 10-04-2022 | 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1 Package NDCs: 51754-5001-5; 51754-5001-4; 51754-5011-4; 51754-5002-5; 51754-5012-4; 51754-5001-1 | Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration | Exela Pharma Sciences LLC / 2,123,040 vials | Class I | Terminated |
| D-0018-2023 | 09-30-2022 | Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01 Package NDCs: 66689-406-01; 66689-406-10 | cGMP Deviations: Out of specification for assay of one of the preservative ingredients. | VistaPharm, Inc. / 1980 cups | Class II | Terminated |
| D-0010-2023 | 09-30-2022 | Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7 Package NDCs: 50742-317-25 | Out of specification for related substances (impurities). | Ingenus Pharmaceuticals Llc / 6176 bottles | Class II | Completed |
| D-0020-2023 | 09-30-2022 | Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe) Package NDCs: 55150-230-00; 55150-230-02; 55150-230-10; 55150-231-00; 55150-231-02; 55150-231-10; 55150-232-00; 55150-232-02; 55150-232-10; 55150-233-00; 55150-233-02; 55150-233-10 | Subpotent Drug: Out of specification for assay | AuroMedics Pharma LLC / 11,520 units | Class II | Terminated |
| D-1550-2022 | 09-29-2022 | Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. Package NDCs: 69097-168-48; 69097-168-87; 69097-168-64; 69097-168-32; 69097-168-53 | Lack of Assurance of Sterility: environmental monitoring failure. | CIPLA / 9041 cartons | Class II | Terminated |
| D-0019-2023 | 09-29-2022 | Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10 Package NDCs: 60429-025-90; 60429-025-10; 60429-026-90; 60429-026-10; 60429-027-90; 60429-027-10 | Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets | Golden State Medical Supply Inc. / 2,584 Bottles | Class I | Terminated |
| D-0003-2023 | 09-27-2022 | Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton) Package NDCs: 0409-5921-16; 0409-5921-01; 0409-5922-16; 0409-5922-01 | Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial. | Pfizer Inc. / 103,150 10 mL vials | Class II | Terminated |
| D-1551-2022 | 09-26-2022 | Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10 Package NDCs: 55150-188-10 | Presence of Particulate Matter: Piece of metal found in a vial | AuroMedics Pharma LLC / 88080 vials | Class III | Ongoing |
| D-0013-2023 | 09-26-2022 | Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10. Package NDCs: 55150-154-10; 55150-155-20 | Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial. | AuroMedics Pharma LLC / 89400 vials | Class II | Completed |
| D-1542-2022 | 09-21-2022 | Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A | Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial. | Viatris Inc / 3,931 cartons | Class II | Terminated |
| D-1547-2022 | 09-21-2022 | Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30 | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). | Akorn, Inc. / 18,145 bottles | Class II | Ongoing |
| D-1548-2022 | 09-21-2022 | Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031. | Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP). | Akorn, Inc. / 177,439 bottles | Class II | Ongoing |
| D-1544-2022 | 09-20-2022 | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07. | Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL). | QuVa Pharma, Inc. / 1994 bags | Class III | Terminated |
| D-1541-2022 | 09-19-2022 | Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01 Package NDCs: 29300-468-05; 29300-468-10; 29300-468-50; 29300-468-01; 29300-136-01; 29300-136-05; 29300-136-10; 29300-136-50; 29300-137-01; 29300-137-05; 29300-137-10; 29300-137-25; 29300-135-01; 29300-135-05; 29300-135-10; 29300-135-50 | Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets, | UNICHEM PHARMACEUTICALS USA INC / 18,960 bottles of 100 | Class III | Terminated |
| D-1543-2022 | 09-16-2022 | Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15. Package NDCs: 0078-0246-61; 0078-0246-15; 0078-0248-61; 0078-0248-15; 0078-0274-22 | CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content. | Novartis Pharmaceuticals Corporation / 132,999 cartons | Class II | Terminated |
| D-1549-2022 | 09-16-2022 | Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45 | Failed Viscosity specification: Slightly higher OOS results obtained for viscosity | ALMIRALL, LLC / 5,315 tubes | Class III | Terminated |
| D-1545-2022 | 09-15-2022 | Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86. Package NDCs: 69097-318-86; 69097-318-87; 69097-318-32; 69097-318-53; 69097-319-86; 69097-319-87; 69097-319-32; 69097-319-53; 69097-321-86; 69097-321-87; 69097-321-32; 69097-321-53 | Lack of Assurance of Sterility | CIPLA / 641,160 ampules | Class II | Terminated |
| D-1538-2022 | 09-15-2022 | Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00 | Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. | RemedyRepack Inc. / 1,699 blister cards/30 tablets each | Class II | Terminated |
| D-0001-2023 | 09-14-2022 | Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon Technologies International 8810 Commodity Circle STE 22-23, Orlando, FL 32819, UPC 6 96952 12904 5 | GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Salon Technologies International Inc / 1656 bottles | Class II | Terminated |
| D-0002-2023 | 09-14-2022 | Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles, Dist. By Antica Farmacista Seattle, WA 98122 UPC 8 47005 00450 9 | Chemical Contamination: product found to contain benzene | Salon Technologies International Inc / 512 bottles | Class I | Terminated |
| D-0007-2023 | 09-14-2022 | Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16 Package NDCs: 43598-405-11; 43598-405-16 | Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content. | Dr. Reddy's Laboratories, Inc. / 2,838 ampules | Class III | Completed |
| D-1536-2022 | 09-13-2022 | Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03 Package NDCs: 68180-512-02; 68180-512-30; 68180-512-09; 68180-512-01; 68180-512-03; 68180-513-30; 68180-513-03; 68180-513-01; 68180-513-09; 68180-513-02; 68180-513-05; 68180-517-03; 68180-517-01; 68180-517-30; 68180-517-09; 68180-517-04; 68180-517-02; 68180-980-03; 68180-980-30; 68180-980-01; 68180-980-09; 68180-980-05; 68180-980-02; 68180-981-01; 68180-981-03; 68180-981-30; 68180-981-09; 68180-981-02; 68180-981-05; 68180-982-01; 68180-982-02; 68180-982-30; 68180-982-03; 68180-982-09; 68180-979-01; 68180-979-03; 68180-979-30; 68180-979-09; 68180-514-01; 68180-514-02; 68180-514-03; 68180-514-09; 68180-514-30; 68180-514-05; 68180-515-01; 68180-515-02; 68180-515-03; 68180-515-09; 68180-515-30; 68180-515-05; 68180-516-01; 68180-516-02; 68180-516-03; 68180-516-09; 68180-516-30 | Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. | Lupin Pharmaceuticals Inc. / 11,802 1000-count bottles | Class II | Terminated |
| D-1535-2022 | 09-12-2022 | Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80. Package NDCs: 72189-330-80 | CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. | Direct Rx / 20 tubes | Class II | Completed |
| D-0008-2023 | 09-09-2022 | Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53220 1 | Marketed Without An Approved NDA/ANDA; Unapproved new drug | Justified Laboratories / Unknown | Class II | Terminated |
| D-0009-2023 | 09-09-2022 | Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8 | Marketed Without An Approved NDA/ANDA; Unapproved new drug | Justified Laboratories / Unknown | Class II | Terminated |
| D-1537-2022 | 09-01-2022 | Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are not available, Alcohol 80% Topical Solution, Antiseptic, 8.5 oz./ 250 mL bottles, Made and Distributed by: Superior Glove Works Ltd., 36 Vimy Street, Acton, Ontario, L7J 1S1, Canada, Made in Canada, UPC: 779406201594. | CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits. | SUPERIOR GLOVE WORKS, LTD. / 7,296 bottles | Class II | Terminated |
| D-1495-2022 | 08-31-2022 | Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31 | cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause. | Akorn, Inc. / 82,689 tubes | Class II | Terminated |
| D-1496-2022 | 08-31-2022 | Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35 | cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause. | Akorn, Inc. / 48,636 tubes | Class II | Terminated |
| D-0006-2023 | 08-30-2022 | Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S, 800-323-2251, Made in USA, NDC 11429-1010-8 Package NDCs: 11429-1010-1; 11429-1010-7; 11429-1010-3; 11429-1010-8 | Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label. | Woodbine Products Co Inc / 595 cases (4 bottles per case) | Class III | Terminated |
| D-1539-2022 | 08-29-2022 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02. Package NDCs: 0555-0971-02; 0555-0775-02; 0555-0972-02; 0555-0776-02; 0555-0777-02; 0555-0973-02; 0555-0974-02 | Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product. | Teva Pharmaceuticals USA Inc / 83,703 bottles | Class II | Terminated |
| D-1524-2022 | 08-26-2022 | TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 348 vials | Class II | Completed |
| D-1533-2022 | 08-26-2022 | QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 1 vial | Class II | Completed |
| D-1522-2022 | 08-26-2022 | TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Carolina Infusion / 2 vials | Class II | Completed |
