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-0263-2023 | 01-17-2023 | Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML) bottles, d)12 FL OZ (355 ML) bottles, e)16 FL OZ (473 ML) bottles, f) 64 FL OZ (1892 ML) bottles, g) 128 FL OZ (3785 ML) bottles | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Urban Electric Power / a) 239 bottles, b) 6,352 bottles, c)14,963 bottles, d) 8,117 bottles, e)22 bottles, f)856 bottles, g) 707 bottles | Class II | Terminated |
| D-0264-2023 | 01-17-2023 | Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles. | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Urban Electric Power / 609 bottles | Class II | Terminated |
| D-0173-2023 | 01-16-2023 | Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharmaceuticals, Inc., The Physician's Solution, Prod#: 68788-7383-09. | Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet. | Preferred Pharmaceuticals, Inc. / 9 bottles | Class II | Terminated |
| D-0176-2023 | 01-13-2023 | S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9 Package NDCs: 0487-5901-99 | Short Fill | Nephron Sc Inc / 925,920 vials | Class II | Terminated |
| D-0262-2023 | 01-13-2023 | Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 47335-679-81 Package NDCs: 47335-675-83; 47335-675-81; 47335-675-19; 47335-675-13; 47335-675-18; 47335-676-83; 47335-676-81; 47335-676-19; 47335-676-13; 47335-676-18; 47335-677-83; 47335-677-81; 47335-677-19; 47335-677-13; 47335-677-18; 47335-678-83; 47335-678-81; 47335-678-19; 47335-678-13; 47335-678-18; 47335-679-83; 47335-679-81; 47335-679-19; 47335-679-13; 47335-679-18 | Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory. | SUN PHARMACEUTICAL INDUSTRIES INC / Lot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; Lot # HAD1452A: 6840 Bottles | Class II | Terminated |
| D-0172-2023 | 01-13-2023 | FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01. | Short Fill: Underfilled units. | OurPharma LLC / 768 cassettes | Class III | Terminated |
| D-0175-2023 | 01-13-2023 | Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, NDC 0487-2784-01 UPC 3 04872 78401 4 | Short Fill | Nephron Sc Inc / 387,000 vials | Class II | Terminated |
| D-0177-2023 | 01-12-2023 | 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3. Package NDCs: 0487-4301-25; 0487-4301-10; 0487-4301-05; 0487-4301-50 | CGMP Deviations: potential for trace amounts of product carryover. | Nephron Sc Inc / 378 bags | Class II | Terminated |
| D-0178-2023 | 01-12-2023 | Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3. Package NDCs: 0487-6105-01 | CGMP Deviations: potential for trace amounts of product carryover. | Nephron Sc Inc / 389,730 vials | Class II | Terminated |
| D-0168-2023 | 01-12-2023 | Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India. NDC 16729-134-01 Package NDCs: 16729-134-10; 16729-134-01; 16729-134-16; 16729-134-17; 16729-135-10; 16729-135-01; 16729-135-16; 16729-135-17 | Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet. | Accord Healthcare, Inc. / 87,576 bottles | Class II | Terminated |
| D-0269-2023 | 01-11-2023 | Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories Package NDCs: 68001-500-00; 68001-500-03; 68001-500-08; 68001-501-00; 68001-501-03; 68001-501-08; 68001-502-00; 68001-502-03; 68001-502-08; 68001-503-00 | Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories. | Amerisource Health Services LLC / (a) 6670 100-count (b) 2666 500-count bottles | Class II | Terminated |
| D-0326-2023 | 01-10-2023 | Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. | CGMP Deviations: initiated due to violations of CGMP manufacturing practices | Consolidated Chemical, Inc / 3186 bottles | Class II | Ongoing |
| D-0325-2023 | 01-10-2023 | Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02 | CGMP Deviations: initiated due to violations of CGMP manufacturing practices | Consolidated Chemical, Inc / 4 oz: 6580 bottles; 8 oz: 1248 bottles | Class II | Ongoing |
| D-0099-2023 | 01-06-2023 | Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05 | Lack of Assurance of Sterility | Nephron Sterile Compounding Center LLC / 38,830 syringes | Class II | Terminated |
| D-0162-2023 | 01-05-2023 | Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08 | Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles. | MACLEODS PHARMA USA, INC / 10052 bottles | Class III | Terminated |
| D-0169-2023 | 01-05-2023 | Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01. Package NDCs: 67877-590-30; 67877-590-60; 67877-590-01; 67877-590-05; 67877-590-10; 67877-591-30; 67877-591-60; 67877-591-01; 67877-591-05; 67877-591-10; 67877-592-30; 67877-592-60; 67877-592-01; 67877-592-05; 67877-592-10; 67877-593-30; 67877-593-60; 67877-593-01; 67877-593-05; 67877-593-10 | Failed Dissolution Specification | Ascend Laboratories, LLC / 49,632 bottles | Class II | Terminated |
| D-0170-2023 | 01-05-2023 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-01. Package NDCs: 67877-590-30; 67877-590-60; 67877-590-01; 67877-590-05; 67877-590-10; 67877-591-30; 67877-591-60; 67877-591-01; 67877-591-05; 67877-591-10; 67877-592-30; 67877-592-60; 67877-592-01; 67877-592-05; 67877-592-10; 67877-593-30; 67877-593-60; 67877-593-01; 67877-593-05; 67877-593-10 | Failed Dissolution Specification | Ascend Laboratories, LLC / 6,336 bottles | Class II | Terminated |
| D-0171-2023 | 01-05-2023 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05. Package NDCs: 67877-590-30; 67877-590-60; 67877-590-01; 67877-590-05; 67877-590-10; 67877-591-30; 67877-591-60; 67877-591-01; 67877-591-05; 67877-591-10; 67877-592-30; 67877-592-60; 67877-592-01; 67877-592-05; 67877-592-10; 67877-593-30; 67877-593-60; 67877-593-01; 67877-593-05; 67877-593-10 | Failed Dissolution Specification | Ascend Laboratories, LLC / 2628 bottles | Class II | Terminated |
| D-0167-2023 | 01-04-2023 | SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01. Package NDCs: 10599-003-01 | Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months. | Intersect ENT, Inc. / 9898 pouches | Class III | Terminated |
| D-0119-2023 | 12-30-2022 | Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0124-2023 | 12-30-2022 | QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0120-2023 | 12-30-2022 | QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0108-2023 | 12-30-2022 | QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 6 vials | Class II | Terminated |
| D-0107-2023 | 12-30-2022 | QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 39 vials | Class II | Terminated |
| D-0104-2023 | 12-30-2022 | QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 12 vials | Class II | Terminated |
| D-0113-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0118-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 8 vials | Class II | Terminated |
| D-0106-2023 | 12-30-2022 | TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 750 vials | Class II | Terminated |
| D-0125-2023 | 12-30-2022 | BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 1200 vials | Class II | Terminated |
| D-0114-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 4 vials | Class II | Terminated |
| D-0112-2023 | 12-30-2022 | Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0110-2023 | 12-30-2022 | Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 4 vials | Class II | Terminated |
| D-0102-2023 | 12-30-2022 | Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0123-2023 | 12-30-2022 | TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 36 vials | Class II | Terminated |
| D-0122-2023 | 12-30-2022 | BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 4 vials | Class II | Terminated |
| D-0116-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 4 vials | Class II | Terminated |
| D-0111-2023 | 12-30-2022 | Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 108 vials | Class II | Terminated |
| D-0115-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0105-2023 | 12-30-2022 | QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 56 vials | Class II | Terminated |
| D-0117-2023 | 12-30-2022 | TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 525 vials | Class II | Terminated |
| D-0126-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 2 vials | Class II | Terminated |
| D-0103-2023 | 12-30-2022 | QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 78 vials | Class II | Terminated |
| D-0109-2023 | 12-30-2022 | Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 4 vials | Class II | Terminated |
| D-0121-2023 | 12-30-2022 | TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. | Lack of Assurance of Sterility | Northern VA Compounders PLLC / 8 vials | Class II | Terminated |
| D-0097-2023 | 12-29-2022 | Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA, Package NDCs: 0409-7620-13; 0409-7620-03; 0409-7620-49; 0409-7620-59; 0409-1005-01; 0409-1005-20; 0409-2222-01; 0409-2222-12 | Lack of assurance of sterility: Bags have the potential to leak. | Pfizer Inc. / 62,088 bags | Class II | Completed |
| D-0159-2023 | 12-28-2022 | Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 Package NDCs: 67877-259-30; 67877-260-30 | Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets. | Ascend Laboratories, LLC / 12192 bottles | Class II | Terminated |
| D-0095-2023 | 12-28-2022 | Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20 Package NDCs: 55150-154-10; 55150-155-20 | Presence of Particulate Matter: Customer complaint of dark particles found inside the vial | Eugia US LLC / 45,250 vials | Class II | Ongoing |
| D-0328-2023 | 12-27-2022 | BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-340-01; NDC Blister Pack: 60687-340-11 Package NDCs: 60687-340-11; 60687-340-01; 60687-351-11; 60687-351-01 | Failed Impurities/Degradation Specifications | Amerisource Health Services LLC / 1,416 cartons | Class II | Terminated |
| D-0320-2023 | 12-27-2022 | TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 100GM DEX: 105GM 2700ML, (d) TPN AA: 100GM DEX: 105GM LIP: 45GM 2700ML, (e) TPN: AA100GM ; DEX185GM ; LIP50GM IN 1500ML, (f) TPN: AA 150GM ; DEX 220GM ; LIP 45GM IN 2400 ml, (g) TPN: AA 60GM ; DEX 200GM ; LIP 30GM IN 1500 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 31 bags | Class II | Terminated |
| D-0310-2023 | 12-27-2022 | NAFCILLIN 24GM IN NS 1200ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 16 bags | Class II | Terminated |
| D-0295-2023 | 12-27-2022 | HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00009-0011-04 | Lack of sterility assurance | Sentara Infusion Services / 32 syringes | Class II | Terminated |
| D-0273-2023 | 12-27-2022 | Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300 Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 7 bags | Class II | Terminated |
| D-0291-2023 | 12-27-2022 | Ertapenem (Invanz) 1GM NS 100ML, antibiotic, use with home pump, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 22 bags | Class II | Terminated |
| D-0323-2023 | 12-27-2022 | VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 18 bags | Class II | Terminated |
| D-0279-2023 | 12-27-2022 | CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 8 syringes | Class II | Terminated |
| D-0293-2023 | 12-27-2022 | FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 13 bags | Class II | Terminated |
| D-0313-2023 | 12-27-2022 | PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 14 bags | Class II | Terminated |
| D-0308-2023 | 12-27-2022 | MORPHINE Sulfate (a) 1MG/ML IN NS 350ML, (b) 5MG/ML IN NS 200ML, pain, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 11 bags | Class II | Terminated |
| D-0304-2023 | 12-27-2022 | METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 19 syringes | Class II | Terminated |
| D-0278-2023 | 12-27-2022 | CEFAZOLIN (a) 12GM IN NS 600ML, (b) 2GM IN NS 100ML, (c) 2GM/20ML SW SYRINGE, (d) 3GM IN NS 150ML, antibiotic, used with a curlin, home or no pump assigned. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 111 bags total 21 syringes total | Class II | Terminated |
| D-0285-2023 | 12-27-2022 | D5W1/2NS W/ 77MEQ OF SOD ACETATE 1000ML, Hydration, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 8 bags | Class II | Terminated |
| D-0290-2023 | 12-27-2022 | DOBUTAMINE, (a) 1080MG IN D5W 270ML, (b) 760MG IN D5W 190ML, ionotrop, used with a home pump, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 4 | Class II | Terminated |
| D-0322-2023 | 12-27-2022 | Vancomycin (a) 1.25GM IN NS 250ML, (b) 1.5GM IN NS 300ML, (c) 1000MG IN NS 200ML (d) 2GM IN 400ML NS, (e) 900MG IN NS 180ML, (f) 500 MG NS 100ML, (g) 750 MG NS 150ML, antibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 155 bags | Class II | Terminated |
| D-0282-2023 | 12-27-2022 | CEFTRIAXONE (a) 1GM IN NS 50ML, (b)4GM IN NS 200ML, (c) 8GM IN NS 400ML, antibiotic, Rx only, used in a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / bags | Class II | Terminated |
| D-0298-2023 | 12-27-2022 | INTRALIPID 18GM, TPN, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 7 bags | Class II | Terminated |
| D-0292-2023 | 12-27-2022 | ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 17 syringes | Class II | Terminated |
| D-0287-2023 | 12-27-2022 | DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 17 bags | Class II | Terminated |
| D-0297-2023 | 12-27-2022 | IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curlin Pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 63323-0322-25 | Lack of sterility assurance | Sentara Infusion Services / 7 bags | Class II | Terminated |
| D-0275-2023 | 12-27-2022 | AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 14 bags | Class II | Terminated |
| D-0315-2023 | 12-27-2022 | PIPERACILLIN / TAZOBACTAM (a) 4.5GM IN NS 100 ML, (b)18GM IN NS 267M, (c) 27GM IN NS 400ML, (d) 3.375 GM IN NS 50ML, (e) 36 GM IN NS 533 ML, antibiotic, Rx only, use with a Curlin or home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 78 bags | Class II | Terminated |
| D-0301-2023 | 12-27-2022 | Levaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 14 bags | Class II | Terminated |
| D-0299-2023 | 12-27-2022 | KYTRIL 350MCG IN 3.5ML NS SYRINGE, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 14 syringes | Class II | Terminated |
| D-0276-2023 | 12-27-2022 | Ampicillin/Sulbactam 3GM IN NS 100ML, antibiotic, Rx only, used with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 20 bags | Class II | Terminated |
| D-0302-2023 | 12-27-2022 | LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 7 syringes | Class II | Terminated |
| D-0283-2023 | 12-27-2022 | CEFTRIAXONE (a) 2GM in NS 100ml, (b) 4GM IN NS 200ML, Antibiotic, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 72 bags | Class II | Terminated |
| D-0312-2023 | 12-27-2022 | ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 15 bags | Class II | Terminated |
| D-0306-2023 | 12-27-2022 | METRONIDAZOLE 500MG 100ML, antibiotic, Rx Only, use with a home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 30 bags | Class II | Terminated |
| D-0318-2023 | 12-27-2022 | TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LIP1800ML, (d)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (e) 55GM DEX:285GM 1800ML, Rx Only, use with Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 26 bags | Class II | Terminated |
| D-0289-2023 | 12-27-2022 | Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 15 bags | Class II | Terminated |
| D-0296-2023 | 12-27-2022 | HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00409-2634-50 | Lack of sterility assurance | Sentara Infusion Services / 37 bags | Class II | Terminated |
| D-0321-2023 | 12-27-2022 | TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA 80GM ; DEX 320GM ; LIP 50GM IN 2300 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 24 bags | Class II | Terminated |
| D-0277-2023 | 12-27-2022 | CASPOFUNGIN 50MG IN NS 100ML, used with a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 7 bags | Class II | Terminated |
| D-0300-2023 | 12-27-2022 | Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500ML (NDC 00338-0117-03)hydration, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 25 bags | Class II | Terminated |
| D-0288-2023 | 12-27-2022 | Dextrose 10% 720ML, TPN, Rx only, use with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 1 bag | Class II | Terminated |
| D-0280-2023 | 12-27-2022 | CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 71 bags total | Class II | Terminated |
| D-0281-2023 | 12-27-2022 | CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 3 bags | Class II | Terminated |
| D-0284-2023 | 12-27-2022 | D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 2 | Class II | Terminated |
| D-0317-2023 | 12-27-2022 | TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 2 bags | Class II | Terminated |
| D-0311-2023 | 12-27-2022 | NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 31 syringes | Class II | Terminated |
| D-0096-2023 | 12-27-2022 | Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06 Package NDCs: 59746-113-06; 59746-113-10; 59746-115-06; 59746-115-10 | Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. | Jubilant Cadista Pharmaceuticals, Inc. / 14,061 bottles | Class III | Terminated |
| D-0274-2023 | 12-27-2022 | AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 19 bags | Class II | Terminated |
| D-0294-2023 | 12-27-2022 | GANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiviral, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 5 bags | Class II | Terminated |
| D-0307-2023 | 12-27-2022 | Milrinone (a) 104MG IN 0.45% NS 130ML,(b) 108MG IN 0.45% NS 135ML, (c) 120MG IN 0.45% NS 150ML, (d) 136MG IN 0.45% NS 170ML, (e) 144MG IN 0.45% NS 180ML, (f) 160MG IN 0.45% NS 200ML, (g) 168MG IN 0.45% NS 210ML, (h) 192MG IN 0.45% NS 240ML, (i) 44MG IN 0.45% NS 55 ML, (j) 52MG IN 0.45% NS 65ML, (k) 56MG IN 0.45% NS 70ML, (l) 68MG IN 0.45% NS 85ML, (m) 84MG IN 0.45% NS 105ML, (n) 88MG IN 0.45% NS 110ML, (o) 92MG IN 0.45% NS 115ML, (p) 96MG IN 0.45% NS 120ML, ionotrop, Rx Only, use with a Curlin or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 83 bags | Class II | Terminated |
| D-0314-2023 | 12-27-2022 | PENICILLIN (a) 40MU IN D5W 400ML(CONTINUOUS), (b) 40U IN D5W 400ML(CONTINUOUS), (c) 48MU IN D5W 480ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 8 bags | Class II | Terminated |
| D-0272-2023 | 12-27-2022 | 0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)1000ML (b)2000ML (c) 720ML, used with Curlin pump, no pump or gravity. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 114 bags total | Class II | Terminated |
| D-0324-2023 | 12-27-2022 | VITAMIN K(PHYTONADIONE) 2.5MG(0.25ML) SYRINGE, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, | Lack of sterility assurance | Sentara Infusion Services / 1 bag | Class II | Terminated |
| D-0303-2023 | 12-27-2022 | MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML, antibiotic, Rx Only, use with home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 91 bags | Class II | Terminated |
| D-0305-2023 | 12-27-2022 | Methylprednisolone 12MG IN NS 1.2ML SYRINGE, steroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 27 syringes | Class II | Terminated |
| D-0319-2023 | 12-27-2022 | TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c) 108GM/AA, 330GM/DEX, 60GM/LIP 3000ML, (d) 37GM/AA, 160GM/DEX 1450ML, (e) 37GM/AA, 160GM/DEX, 25GM/LIP 1450ML, (f) 74-100GM OF PROTEIN B4197 74 Gm, (g) 75GM/AA, 200GM/DEX, 43GM/LIP 2500ML, (h) 90GM/AA ; 255GM/DEX ; 50GM/LIP 3500 ml, (i) 90GM/AA ; 255GMDEX 3500 ml, (j) TPN AA 100GM DEX: 320GM LIP: 50GM 2400ML, (k) TPN AA 30GM DEX: 145GM 1210ML, (l) TPN AA 30GM DEX: 145GM LIP: 35GM 1210ML, (m)TPN AA 42GM DEX: 432GM 2070ML, (n) TPN AA 50GM DEX: 130GM 2500ML, (o) TPN AA 55GM DEX:180GM 1000ML, (p) TPN AA 70GM DEX:290GM 2100ML, (q) TPN AA 70GM DEX:290GM 2500ML, (r) TPN AA 80GM DEX:200GM 1900ML, (s) TPN AA 80GM DEX:200GM LIP:38GM 1900ML, (t) TPN AA 30GM ; DEX 82GM ; IN 890 ml, (u) TPN AA 30GM ; DEX 82GM ; LIP 18GM IN 890 ml, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 111 bags | Class II | Terminated |
| D-0316-2023 | 12-27-2022 | Sodium Chloride 0.9 % (a) 100ML (MAGNESIUM) (b) 69.3ML, (c) 71.4ML, (d) 77.7ML, (e) 130ML, (f) 210ML, (g) 190ML, (h) 220ML: diluent, Rx Only, use with Curlin or Sapphire pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 11 bags | Class II | Terminated |
