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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0181-2023 | 12-06-2022 | Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UPC 3 0573 0154 21 5), Pfizer, Madison, NJ 07940 | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back | Glaxosmithkline Consumer Healthcare Holdings DBA Haleon / 321,246 tablets | Class I | Terminated |
| D-0094-2023 | 12-06-2022 | Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26 Package NDCs: 31722-627-26; 31722-627-46 | Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content | Camber Pharmaceuticals, Inc / N/A | Class III | Terminated |
| D-0077-2023 | 12-05-2022 | Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00. | Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency. | RemedyRepack Inc. / 9 boxes | Class II | Terminated |
| D-0077-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0076-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0078-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0075-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0074-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0073-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0079-2024 | 12-02-2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8 | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | GlaxoSmithKline Consumer Healthcare Holdings LLC / N/A | Class II | Completed |
| D-0086-2023 | 12-01-2022 | Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637. | Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL | BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy / 250 syringes | Class I | Terminated |
| D-0085-2023 | 12-01-2022 | Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. Package NDCs: 62756-183-83; 62756-183-88; 62756-183-08; 62756-183-13; 62756-183-18; 62756-184-83; 62756-184-88; 62756-184-08; 62756-184-13; 62756-184-18; 62756-185-83; 62756-185-88; 62756-185-08; 62756-185-13; 62756-185-18 | Presence of foreign substance | SUN PHARMACEUTICAL INDUSTRIES INC / Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles | Class II | Terminated |
| D-0131-2023 | 11-29-2022 | Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05 | Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial | Accord Healthcare, Inc. / Unknown | Class I | Terminated |
| D-0078-2023 | 11-29-2022 | FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01 | Underfilled units. | OurPharma LLC / 691 cassettes | Class II | Terminated |
| D-0080-2023 | 11-28-2022 | 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 / 37,320 vials | Class I | Terminated |
| D-0079-2023 | 11-28-2022 | 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 / 489,600 vials | Class I | Terminated |
| D-0076-2023 | 11-25-2022 | 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Package NDCs: 0264-5802-00; 0264-5802-10; 0264-5804-00; 0061832446 | Lack of sterility assurance: Bags have the potential to leak. | B. Braun Medical, Inc. / 756 bags | Class II | Terminated |
| D-0072-2023 | 11-23-2022 | Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 23155-490-01 Package NDCs: 23155-489-01; 23155-489-05; 23155-490-01; 23155-490-05 | Subpotent Drug | Heritage Pharmaceuticals Inc / 13805 Bottles each containing 100 tablets | Class II | Terminated |
| D-0127-2023 | 11-22-2022 | Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-472-03; 63323-472-17; 63323-472-01; 63323-472-37; 63323-463-01; 63323-463-57; 63323-461-01; 63323-461-57; 63323-468-02; 63323-468-37; 63323-468-01; 63323-468-17 | Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. | Fresenius Kabi USA, LLC / 40,375 vials | Class II | Terminated |
| D-0075-2023 | 11-22-2022 | 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. / 4,097 cases/12 bags per case | Class II | Ongoing |
| D-0129-2023 | 11-22-2022 | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-472-03; 63323-472-17; 63323-472-01; 63323-472-37; 63323-463-01; 63323-463-57; 63323-461-01; 63323-461-57; 63323-468-02; 63323-468-37; 63323-468-01; 63323-468-17 | Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. | Fresenius Kabi USA, LLC / 31,600 vials | Class II | Terminated |
| D-0128-2023 | 11-22-2022 | Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Package NDCs: 63323-472-03; 63323-472-17; 63323-472-01; 63323-472-37; 63323-463-01; 63323-463-57; 63323-461-01; 63323-461-57; 63323-468-02; 63323-468-37; 63323-468-01; 63323-468-17 | Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. | Fresenius Kabi USA, LLC / 40,025 vials | Class II | Terminated |
| D-0073-2023 | 11-21-2022 | Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton, NDC49032-273-30; Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 25,176, 30-count; 22,968 20-count | Class III | Terminated |
| D-0071-2023 | 11-16-2022 | Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3. Package NDCs: 68968-5552-3; 68968-5553-3; 68968-5554-3; 68968-5555-3 | Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals Inc / 3977 boxes | Class II | Ongoing |
| D-0070-2023 | 11-14-2022 | Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 Package NDCs: 42192-614-10; 42192-614-30; 42192-614-05 | Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. | Acella Pharmaceuticals, LLC / 637 cartons | Class III | Terminated |
| D-0069-2023 | 11-14-2022 | Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 Package NDCs: 42192-614-10; 42192-614-30; 42192-614-02 | Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode. | Acella Pharmaceuticals, LLC / 574 cartons | Class III | Terminated |
| D-0074-2023 | 11-14-2022 | Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60 | Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period. | Acella Pharmaceuticals, LLC / 528 cartons | Class III | Terminated |
| D-0065-2023 | 11-10-2022 | PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2. | CGMP Deviations: Potential for cross contamination due to product carry over. | Nephron Sterile Compounding Center LLC / 56,220 vials | Class II | Terminated |
| D-0064-2023 | 11-10-2022 | PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6. | CGMP Deviations: Potential for cross contamination due to product carry over. | Nephron Sterile Compounding Center LLC / 34,020 vials | Class II | Terminated |
| D-0061-2023 | 11-10-2022 | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01 | Failed Impurities/Degradation Specifications | Par Formulations Private Limited / 218 bottles/100 capsules per bottle | Class II | Terminated |
| D-0161-2023 | 11-09-2022 | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10 | Failed Impurity/Degradation Specifications | Lannett Company Inc. / 20,040 bottles | Class III | Terminated |
| D-0062-2023 | 11-09-2022 | 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 Package NDCs: 0990-7730-36; 0990-7730-37; 0990-7983-61; 0990-7983-02; 0990-7983-03; 0990-7983-09; 0990-7983-55; 0990-7983-53; 0990-7984-37; 0990-7984-20; 0990-7984-13; 0990-7984-23; 0990-7984-36; 0990-7985-02; 0990-7985-03; 0990-7985-09 | Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility. | ICU Medical Inc / 137,120 bags | Class II | Ongoing |
| D-0060-2023 | 11-09-2022 | Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ. | Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost. | ImprimisRx NJ / 960 bottles | Class II | Terminated |
| D-0261-2023 | 11-09-2022 | Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum, Topical Cream, Net weight 0.78 oz (22g) tube, UPC 8 60322 00180 8, Manufactured by: Dr. Retter EC Warszawska 17, 05-075 Warszawa Poland | CGMP deviations | DISCOVERY PHARMA LLC / 21,892 tubes | Class II | Terminated |
| D-0160-2023 | 11-09-2022 | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10 | Failed Impurity/Degradation Specifications | Lannett Company Inc. / 5,640 bottles | Class III | Terminated |
| D-0066-2023 | 11-05-2022 | Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO. | Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol. | Adam's Polishes LLC / 3,441 gallons total | Class I | Ongoing |
| D-0067-2023 | 11-05-2022 | Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO. | CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol. | Adam's Polishes LLC / 3,441 gallons total | Class II | Ongoing |
| D-0101-2023 | 11-02-2022 | Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05 | cGMP deviation: discontinue of stability support for product. | Direct Rx / 11 bottles | Class II | Terminated |
| D-0063-2023 | 10-21-2022 | Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05 | Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness. | Viatris Inc / 2,794 bottles | Class II | Terminated |
| D-0025-2023 | 10-18-2022 | Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990. Package NDCs: 50242-078-12; 50242-078-55; 8100425900; 0081004259 | Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning. | Genentech Inc / 452 vials and implants | Class III | Terminated |
| D-0024-2023 | 10-18-2022 | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83 Package NDCs: 62756-969-83; 62756-969-64; 62756-970-83; 62756-970-64 | Presence of Foreign Substance | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Terminated |
| D-0059-2023 | 10-13-2022 | Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA. | Failed Stability Specifications | Aadi Bioscience / 2,333 vials | Class III | Terminated |
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
