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-1113-2023 | 08-17-2023 | rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 3519 Syringes | Class II | Terminated |
| D-1120-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 132 bags | Class II | Terminated |
| D-1128-2023 | 08-17-2023 | PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 340 bags | Class II | Terminated |
| D-1107-2023 | 08-17-2023 | CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 304 bags | Class II | Terminated |
| D-1124-2023 | 08-17-2023 | PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 4100 syringes | Class II | Terminated |
| D-1130-2023 | 08-17-2023 | EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 292 bags. | Class II | Terminated |
| D-1143-2023 | 08-16-2023 | Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03 Package NDCs: 72426-818-03; 72426-818-99; 72426-818-09 | Failed dissolution specifications: below specification results at stability 12-month | Esperion / 45,240 bottles | Class III | Terminated |
| D-1105-2023 | 08-15-2023 | Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding. | Lack of Assurance of Sterility | TMC Acquisitions LLC dba Tailor Made Compounding / 9 vials | Class II | Terminated |
| D-1106-2023 | 08-15-2023 | NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding. | Lack of Assurance of Sterility | TMC Acquisitions LLC dba Tailor Made Compounding / 99 vials | Class II | Terminated |
| D-1104-2023 | 08-14-2023 | All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar. | CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling. | Inmar Supply Chain Solutions, LLC / Unknown | Class II | Ongoing |
| D-1144-2023 | 08-14-2023 | Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10 Package NDCs: 72485-501-01; 72485-501-10; 72485-502-01; 72485-502-10; 72485-503-01 | Failed Impurities/Degradation Specifications | Caplin Steriles Limited / 19, 820 vials | Class III | Terminated |
| D-1103-2023 | 08-14-2023 | Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01. Package NDCs: 10019-079-01 | Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial. | Baxter Healthcare Corporation / 13,502 vials | Class III | Completed |
| D-1095-2023 | 08-14-2023 | Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01 Package NDCs: 68462-329-01; 68462-329-10; 68462-295-01; 68462-295-10; 68462-295-90; 68462-296-01; 68462-296-10; 68462-296-90; 68462-294-01; 68462-294-10; 68462-294-90 | Subpotent: Out of Specification for Assay Test at the 3-month time point. | Glenmark Pharmaceuticals Inc., USA / 1,200 bottles | Class III | Ongoing |
| D-1140-2023 | 08-11-2023 | DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Package NDCs: 0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0427-52; 0941-0427-53; 0941-0429-52; 0941-0429-53; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0484-01; 0941-0487-01; 0941-0490-01 | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. | Baxter Healthcare Corporation / a) 44,520; b) 60,762; c) 483,912 | Class II | Terminated |
| D-1141-2023 | 08-11-2023 | Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07 Package NDCs: 0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0427-52; 0941-0427-53; 0941-0429-52; 0941-0429-53; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0484-01; 0941-0487-01; 0941-0490-01 | Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. | Baxter Healthcare Corporation / 22,112 bags | Class II | Terminated |
| D-1147-2023 | 08-11-2023 | Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478 Package NDCs: 50268-195-60 | Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste | AVKARE LLC / 35,184 cartons | Class II | Terminated |
| D-1146-2023 | 08-11-2023 | Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478 Package NDCs: 42291-741-51 | Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste | AVKARE LLC / 35,184 tubes | Class II | Terminated |
| D-1094-2023 | 08-10-2023 | Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05. | Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range. | Imprimis NJOF, LLC / 2,683 bottles | Class III | Terminated |
| D-1084-2023 | 08-10-2023 | hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distributed by Hello Products LLC, Montclair, NJ 07042, UPC 8 19156 02026 4 (carton), 12-count case GTIN: 20819156020268; strawberry tubes also sold in Strawberry 3-pack overwrap UPC 8 19156 02349 4, UPC 10819156023491 case; in the variety 3-pack of Strawberry + Unicorn + Grape UPC 8 19156 02332 6, UPC 10819156023323 case; and in a 24-count Toothpaste Floorstand, UPC 819156020684 (case). | Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste. | Colgate Palmolive Company / 182,046 tubes | Class II | Terminated |
| D-1101-2023 | 08-09-2023 | AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065. | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Ecometics, Inc. / 92,967 vials | Class II | Completed |
| D-1097-2023 | 08-09-2023 | YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169 00004 6, and 8 FL OZ (236 mL) bottles, UPC 0 11169 00008 4, The Oakhurst Co., Dist., Levittown, NY 11756. | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Ecometics, Inc. / a) 5028 bottles; b) 9809 bottles | Class II | Completed |
| D-1100-2023 | 08-09-2023 | activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155. | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Ecometics, Inc. / 32,583 bottles | Class II | Completed |
| D-1096-2023 | 08-09-2023 | Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756. | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Ecometics, Inc. / a) 9816 bottles; b) 10,776 bottles | Class II | Completed |
| D-1098-2023 | 08-09-2023 | ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854. | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Ecometics, Inc. / a) 52,879 bottles; b) 12,054 bottles | Class II | Completed |
| D-1102-2023 | 08-09-2023 | Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064. | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Ecometics, Inc. / 38,486 vials | Class II | Completed |
| D-1099-2023 | 08-09-2023 | Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company, Levittown, NY 11756. | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Ecometics, Inc. / a) 6,120 tubes, b) 540 tubes | Class II | Completed |
| D-1085-2023 | 08-07-2023 | PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injection, 9.2 mL Single-dose vial, Manufacturer: Advanced Accelerator Appllications USA, Inc., 57 E. Willow Street NJ 07041, Milburn, USA, NDC 69488-010-61 | Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot number and expiration date | Advanced Accelerator Applications USA, Inc. / 10 | Class III | Terminated |
| D-1150-2023 | 08-03-2023 | Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885 | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug. | APG SEVEN, INC / 120 bottles | Class I | Ongoing |
| D-1092-2023 | 08-02-2023 | Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004 | CGMP Deviations | Parker Laboratories, Inc. / 40 | Class II | Terminated |
| D-1089-2023 | 08-02-2023 | Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004 | CGMP Deviations | Parker Laboratories, Inc. / 9 | Class II | Terminated |
| D-1171-2023 | 08-02-2023 | Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93 | Failed dissolution specifications - results obtained were below spec average. | Aurobindo Pharma USA Inc. / 9,890 bottles | Class II | Terminated |
| D-1090-2023 | 08-02-2023 | Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon with pump (NDC 30775-051-50), g) Starter Kit (NDC 30775-051-95), Parker Laboratories, Inc. 286 Eldridge Road Fairfield, NJ 07004 | CGMP Deviations | Parker Laboratories, Inc. / 250 | Class II | Terminated |
| D-1091-2023 | 08-02-2023 | Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC 30775-052-03) and b) 4 fl. oz. tube (NDC 30775-052-04) Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004 | CGMP Deviations | Parker Laboratories, Inc. / 8 | Class II | Terminated |
| D-1093-2023 | 08-02-2023 | Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. tubes (NDC 30775-054-02), and c) 4 fl. oz. tubes (NDC 30775-054-04), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004 | CGMP Deviations | Parker Laboratories, Inc. / 50 | Class II | Terminated |
| D-1083-2023 | 08-02-2023 | 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00 Package NDCs: 0264-5802-00; 0264-5802-10; 0264-5804-00; 0061852531 | Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed. | B. Braun Medical Inc. / 43,812 bags | Class III | Terminated |
| D-1086-2023 | 07-27-2023 | Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05 Package NDCs: 62332-518-05 | Failed Impurities/Degradation Specifications | ALEMBIC PHARMACEUTICALS, INC. / 82,400 bottles | Class III | Ongoing |
| D-1088-2023 | 07-21-2023 | Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-617-08 Package NDCs: 59651-616-08; 59651-617-08 | cGMP deviations: Batch was released prior to approval. | Aurobindo Pharma USA Inc. / 48 bottles | Class II | Terminated |
| D-0946-2023 | 07-21-2023 | Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not For Inhalation or Injection, Must be Diluted, Manufactured by: The Ritedose Corporation Columbia, SC 29203 for Ritedose Pharmaceuticals, LLC Columbia, SC 29203, NDC 76204-025-96. | CGMP deviation: product released prior to supplier approval. | The Ritedose Corporation / 44 cartons | Class II | Completed |
| D-1087-2023 | 07-21-2023 | Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-616-08 Package NDCs: 59651-616-08; 59651-617-08 | cGMP deviations: Batch was released prior to approval. | Aurobindo Pharma USA Inc. / 48 bottles | Class II | Terminated |
| D-0945-2023 | 07-20-2023 | FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40 | cGMP deviations: due to shipment of rejected units. | SCA Pharmaceuticals / 183 bags | Class II | Terminated |
| D-1082-2023 | 07-18-2023 | Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86 Package NDCs: 47335-061-86; 47335-061-66; 47335-061-79; 47335-062-86; 47335-062-66; 47335-062-79; 47335-063-86; 47335-063-66; 47335-063-79 | Out of Specification result observed in content uniformity testing | SUN PHARMACEUTICAL INDUSTRIES INC / 360 60-count bottles | Class III | Terminated |
| D-1145-2023 | 07-18-2023 | Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57 Package NDCs: 67877-749-57 | Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability. | Ascend Laboratories, LLC / 99,516 sachets | Class III | Terminated |
| D-1061-2023 | 07-17-2023 | fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 8,146 bags | Class II | Terminated |
| D-1066-2023 | 07-17-2023 | PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 81,073 syringes | Class II | Terminated |
| D-1043-2023 | 07-17-2023 | fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 5,124 syringes | Class II | Terminated |
| D-1077-2023 | 07-17-2023 | PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 10,494 syringes | Class II | Terminated |
| D-1074-2023 | 07-17-2023 | lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6006-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 9,517 syringes | Class II | Terminated |
| D-1045-2023 | 07-17-2023 | fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 150 syringes | Class II | Terminated |
| D-1069-2023 | 07-17-2023 | fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 295 bags | Class II | Terminated |
| D-1059-2023 | 07-17-2023 | fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 19,014 bags | Class II | Terminated |
| D-1075-2023 | 07-17-2023 | midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 621 syringes | Class II | Terminated |
| D-1050-2023 | 07-17-2023 | fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 848 bags | Class II | Terminated |
| D-1058-2023 | 07-17-2023 | HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 2,077 syringes | Class II | Terminated |
| D-1065-2023 | 07-17-2023 | morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-3 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 720 syringes | Class II | Terminated |
| D-1049-2023 | 07-17-2023 | HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 2,228 syringes | Class II | Terminated |
| D-1051-2023 | 07-17-2023 | fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 94 bags | Class II | Terminated |
| D-1079-2023 | 07-17-2023 | fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 6,770 syringes | Class II | Terminated |
| D-1080-2023 | 07-17-2023 | morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2040-4 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 1,235 syringes | Class II | Terminated |
| D-1071-2023 | 07-17-2023 | ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 2,994 syringes | Class II | Terminated |
| D-1042-2023 | 07-17-2023 | fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2001-2 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 1,197 syringes | Class II | Terminated |
| D-1078-2023 | 07-17-2023 | PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 16,971 syringes | Class II | Terminated |
| D-1063-2023 | 07-17-2023 | fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 1,044 bags | Class II | Terminated |
| D-1070-2023 | 07-17-2023 | fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 1,114 bags | Class II | Terminated |
| D-1056-2023 | 07-17-2023 | succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 12,239 syringes | Class II | Terminated |
| D-1047-2023 | 07-17-2023 | fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 1,216 syringes | Class II | Terminated |
| D-1076-2023 | 07-17-2023 | rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6010-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 10,065 syringes | Class II | Terminated |
| D-1060-2023 | 07-17-2023 | HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2012-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 5,259 syringes | Class II | Terminated |
| D-1046-2023 | 07-17-2023 | fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 100 syringes | Class II | Terminated |
| D-1062-2023 | 07-17-2023 | fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 2,340 syringes | Class II | Terminated |
| D-1053-2023 | 07-17-2023 | fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 1669 syringes | Class II | Terminated |
| D-1054-2023 | 07-17-2023 | fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 2,082 syringes | Class II | Terminated |
| D-1057-2023 | 07-17-2023 | HYDROmorphone in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2013-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 1,389 syringes | Class II | Terminated |
| D-1044-2023 | 07-17-2023 | HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 2,717 syringes | Class II | Terminated |
| D-1072-2023 | 07-17-2023 | fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 896 bags | Class II | Terminated |
| D-1055-2023 | 07-17-2023 | HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 2,389 syringes | Class II | Terminated |
| D-1052-2023 | 07-17-2023 | HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-3 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 3824 bags | Class II | Terminated |
| D-1067-2023 | 07-17-2023 | fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 1,486 syringes | Class II | Terminated |
| D-1068-2023 | 07-17-2023 | morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2041-2 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 723 syringes | Class II | Terminated |
| D-1064-2023 | 07-17-2023 | morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 1,699 syringes | Class II | Terminated |
| D-1048-2023 | 07-17-2023 | vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6012-1. | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 2,640 Syringes | Class II | Terminated |
| D-1073-2023 | 07-17-2023 | ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services Inc / 8,942 syringes | Class II | Terminated |
| D-0947-2023 | 07-14-2023 | rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 77,554 Syringes. | Class II | Terminated |
| D-0985-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0400-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 128 bags | Class II | Terminated |
| D-0982-2023 | 07-14-2023 | neostigmine 5 mg/5mL (1mg/mL) Syringe, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6065-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 6,468 Syringes | Class II | Terminated |
| D-0999-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0405-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 84 bags | Class II | Terminated |
| D-0953-2023 | 07-14-2023 | dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 3,699 bags | Class II | Terminated |
| D-0952-2023 | 07-14-2023 | glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use, Syringe, RX ONLY, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6084-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 770 Syringes | Class II | Terminated |
| D-1001-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0427-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 68 bags | Class II | Terminated |
| D-1004-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 224 bags | Class II | Terminated |
| D-0971-2023 | 07-14-2023 | vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride, (3 mg/mL), IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6071-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 1927 bags | Class II | Terminated |
| D-0954-2023 | 07-14-2023 | EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 9,121 bags | Class II | Terminated |
| D-1038-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, low K, Maintenance 4:1 Plasmalyte/Tromethamine, Low Potassium, IV Bag, total volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0112-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 184 bags | Class II | Terminated |
| D-0974-2023 | 07-14-2023 | heparin 2500 units added to 0.9% sodium chloride 250mL, CONCENTRATION = 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8000-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 358 bags | Class II | Terminated |
| D-1037-2023 | 07-14-2023 | Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, IV Bag, total volume = 1047 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 356 bags | Class II | Terminated |
| D-1022-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0008-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 80 bags | Class II | Terminated |
| D-0979-2023 | 07-14-2023 | heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7023-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 5,834 bags | Class II | Terminated |
| D-1041-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-0215-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 104 bags | Class II | Terminated |
| D-0978-2023 | 07-14-2023 | heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7022-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 11,824 bags | Class II | Terminated |
| D-1010-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0408-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 192 bags | Class II | Terminated |
| D-0949-2023 | 07-14-2023 | succinylcholine 200 mg/10 mL (20 mg/mL), Syringe, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue Pheonix, AZ, NDC 72196-6011-2. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 26,208 Syringes | Class II | Terminated |
