Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 08, 2025 and include a total of 16999 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0026-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 3,590 10 mL syringes | Class II | Terminated |
| D-0032-2024 | 09-21-2023 | HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 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: | Central Admixture Pharmacy Services Inc / 398 5 mL syringes | Class II | Terminated |
| D-0014-2024 | 09-21-2023 | fentaNYL in 0.9% sodium chloride, 5,000 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: | Central Admixture Pharmacy Services Inc / 403 bags | Class II | Terminated |
| D-0031-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 2,664 30 mL syringes | Class II | Terminated |
| D-0021-2024 | 09-21-2023 | fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 476, 50 mL Syringes | Class II | Terminated |
| D-0003-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 1,590 5 mL Syringes. | Class II | Terminated |
| D-0017-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 190 250 mL bags | Class II | Terminated |
| D-0005-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 3,384 10 mL syringes | Class II | Terminated |
| D-0010-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 598 10 mL syringes | Class II | Terminated |
| D-0002-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 4,775 5 mL Syringes | Class II | Terminated |
| D-0011-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 688 50 mL syringes | Class II | Terminated |
| D-0038-2024 | 09-21-2023 | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 Package NDCs: 68382-255-06; 68382-255-14; 68382-255-16; 68382-255-01; 68382-255-05; 68382-255-30; 68382-255-77; 68382-256-14; 68382-256-01; 68382-256-16; 68382-256-05; 68382-256-30; 68382-256-77; 68382-256-06; 68382-257-14; 68382-257-01; 68382-257-16; 68382-257-05; 68382-257-30; 68382-257-77; 68382-257-06 | Failed Dissolution Specifications | Zydus Pharmaceuticals (USA) Inc / 7,248 bottles | Class II | Completed |
| D-0008-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 1,389 5 mL syringes | Class II | Terminated |
| D-0022-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 240 100 mL bags | Class II | Terminated |
| D-0015-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 895 50 mL syringes | Class II | Terminated |
| D-0006-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 3,081 syringes | Class II | Terminated |
| D-0007-2024 | 09-21-2023 | PHENYLephrine in 0.9% sodium chloride, 1,000 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: | Central Admixture Pharmacy Services Inc / 19,510 10 mL syringes. | Class II | Terminated |
| D-0013-2024 | 09-21-2023 | fentaNYL in 0.9% sodium chloride, 2,500 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: | Central Admixture Pharmacy Services Inc / 1,792 bags | Class II | Terminated |
| D-0027-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 1,190 30 mL syringes | Class II | Terminated |
| D-0018-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 419 50 mL syringes | Class II | Terminated |
| D-0029-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 4,550 30 mL syringes | Class II | Terminated |
| D-0025-2024 | 09-21-2023 | fentaNYL, 1,250 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: | Central Admixture Pharmacy Services Inc / 1,459 30 mL syringes | Class II | Terminated |
| D-0009-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 1,767 3 mL syringes | Class II | Terminated |
| D-0020-2024 | 09-21-2023 | fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2 | Lack of assurance of sterility: | Central Admixture Pharmacy Services Inc / 174, 5 mL syringes. | Class II | Terminated |
| D-0028-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 1,190 50 mL syringes | Class II | Terminated |
| D-0016-2024 | 09-21-2023 | 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: | Central Admixture Pharmacy Services Inc / 60 250 mL bags | Class II | Terminated |
| D-0043-2024 | 09-20-2023 | MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05 | Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim. | Imprimis NJOF, LLC / 6,228 bags + 15,360 boxes | Class III | Terminated |
| D-0049-2024 | 09-20-2023 | Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01. Package NDCs: 10702-013-01; 10702-014-01 | Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles. | KVK-Tech, Inc. / 1488 bottles | Class I | Terminated |
| D-1178-2023 | 09-12-2023 | Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526. Package NDCs: 62935-753-75; 62935-754-74; 62935-755-75; 62935-223-05; 62935-221-04; 62935-224-05; 62935-303-30; 62935-305-29; 62935-304-30; 62935-453-45; 62935-454-44; 62935-455-45 | Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product. | Tolmar, Inc. / 2990 cartons | Class III | Terminated |
| D-1174-2023 | 09-08-2023 | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22. Package NDCs: 0078-0240-61; 0078-0240-15; 0078-0241-61; 0078-0241-15; 0078-0109-61; 0078-0109-01; 0078-0110-22 | Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals. | Novartis Pharmaceuticals Corp. / 1272 bottles | Class I | Ongoing |
| D-0046-2024 | 09-08-2023 | TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, NJ 08628 | Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis | Church & Dwight Inc / 5,316 bottles | Class I | Ongoing |
| D-1172-2023 | 09-07-2023 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96 Package NDCs: 47335-506-96; 47335-507-97 | Subpotent: Out of Specification result observed for low assay | SUN PHARMACEUTICAL INDUSTRIES INC / 69,707 cartons | Class III | Terminated |
| D-1173-2023 | 09-05-2023 | Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle, DISTRIBUTED BY THEKROGER CO. CINCINNATI, OHIO 45202, UPC 011110380807 | Incorrect/Undeclared Excipients. | Vi-Jon, LLC / 245,904 Bottles | Class III | Terminated |
| D-1148-2023 | 09-05-2023 | Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511. Package NDCs: 71839-122-25; 71839-122-10; 71839-122-01 | Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials. | BE PHARMACEUTICALS AG / 41,148 vials | Class II | Terminated |
| D-1167-2023 | 09-01-2023 | octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 30,490 units | Class II | Ongoing |
| D-1152-2023 | 09-01-2023 | TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-032-15. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,747 | Class II | Ongoing |
| D-1154-2023 | 09-01-2023 | TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-002-11. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 5,509 | Class II | Ongoing |
| D-1151-2023 | 09-01-2023 | TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-027-15. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,747 units | Class II | Ongoing |
| D-1163-2023 | 09-01-2023 | TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-058-15. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,868 units | Class II | Ongoing |
| D-1164-2023 | 09-01-2023 | TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-095-19. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 196,442 units | Class II | Ongoing |
| D-1159-2023 | 09-01-2023 | TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-098-15. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 18,171 units | Class II | Ongoing |
| D-1161-2023 | 09-01-2023 | TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-013-15. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 293,400 units | Class II | Ongoing |
| D-1166-2023 | 09-01-2023 | TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-099-15. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,819 | Class II | Ongoing |
| D-1158-2023 | 09-01-2023 | TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-165-13. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 16,500 units | Class II | Ongoing |
| D-1156-2023 | 09-01-2023 | TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-096-19. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 83,898 units | Class II | Ongoing |
| D-1157-2023 | 09-01-2023 | TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-417-19. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,000 units | Class II | Ongoing |
| D-0039-2024 | 09-01-2023 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11 Package NDCs: 68084-447-11; 68084-447-01 | Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point. | Amerisource Health Services LLC / 3,344 cartons | Class III | Terminated |
| D-1165-2023 | 09-01-2023 | TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 180,315 units | Class II | Ongoing |
| D-1162-2023 | 09-01-2023 | TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-094-19. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,873 | Class II | Ongoing |
| D-1153-2023 | 09-01-2023 | TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-097-19. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 8,810 units | Class II | Ongoing |
| D-1160-2023 | 09-01-2023 | MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38. Package NDCs: 0904-6488-38 | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 282,564 units | Class II | Ongoing |
| D-1155-2023 | 09-01-2023 | TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC:17312-178-15. | Lack of Assurance of Sterility | AMMAN PHARMACEUTICAL INDUSTRIES / 196,111 units | Class II | Ongoing |
| D-1149-2023 | 08-30-2023 | Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16 Package NDCs: 66689-305-16 | Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results | VistaPharm LLC / 14,400 bottles | Class II | Terminated |
| D-1179-2023 | 08-29-2023 | Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in case of 6 jars per case, Distributed by RB Health (US), Parsippany, NJ 07054, NDC 63824-431-90 Package NDCs: 63824-431-90 | Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging. | RB Health (US) LLC / 6,072 cases/36,426 individual selling units | Class III | Terminated |
| D-0035-2024 | 08-26-2023 | Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], Certified Organic by Organic Certifiers. | CGMP Deviations | Dr. Berne's Whole Health Products / 1744 bottles | Class II | Ongoing |
| D-0034-2024 | 08-26-2023 | Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected]. | CGMP Deviations | Dr. Berne's Whole Health Products / 795 bottles | Class II | Ongoing |
| D-0033-2024 | 08-26-2023 | Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001036 | CGMP Deviations | Dr. Berne's Whole Health Products / 6060 bottles | Class II | Ongoing |
| D-0037-2024 | 08-26-2023 | Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001111. | Non-Sterility | Dr. Berne's Whole Health Products / N/A | Class I | Ongoing |
| D-0036-2024 | 08-26-2023 | Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001111. | CGMP Deviations | Dr. Berne's Whole Health Products / 3833 bottles | Class II | Ongoing |
| D-1170-2023 | 08-25-2023 | Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01 | Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg. | Marlex Pharmaceuticals, Inc. / 94/100 count bottles | Class II | Terminated |
| D-1169-2023 | 08-25-2023 | Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01 | Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg. | Marlex Pharmaceuticals, Inc. / 94/100 count bottles | Class I | Terminated |
| D-1168-2023 | 08-25-2023 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case). Package NDCs: 54365-400-31 | Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides. | CareFusion 213, LLC / 398,160 cartons | Class II | Completed |
| D-1180-2023 | 08-25-2023 | WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5 | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug. | Hua Da Trading, Inc. dba Wefun Inc. / 300 cartons | Class I | Ongoing |
| D-0048-2024 | 08-24-2023 | Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01 Package NDCs: 0338-0063-01; 0338-0067-01 | CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake. | Baxter Healthcare Corporation / 472 vials | Class II | Completed |
| D-1139-2023 | 08-23-2023 | Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, NDC# 71428-003-60 Package NDCs: 71428-003-60; 71428-003-30 | Defective Container: slow leakage under the cap | Contract Pharmaceuticals Limited Canada / 11,350 bottles | Class III | Completed |
| D-1177-2023 | 08-22-2023 | Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only, Manufactured by SOFIE Co dba SOFIE, Dulles, VA 20166 for Life Molecular Imagining Ltd., NDC 54828-001-50 Package NDCs: 54828-001-30; 54828-001-50 | Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT). | Sofie Co dba Sofie / 6 patient doses | Class II | Terminated |
| D-1175-2023 | 08-18-2023 | Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01 | Subpotent Drug: Product does not contain SPF that is declared on the label. | HUMANRACE / 5046 units | Class II | Ongoing |
| D-1176-2023 | 08-18-2023 | Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002 | Subpotent Drug: Product does not contain SPF that is declared on the label. | HUMANRACE / 2942 units | Class II | Ongoing |
| D-1138-2023 | 08-17-2023 | dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 703 bags. | Class II | Terminated |
| D-1114-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 84 bags | Class II | Terminated |
| D-1135-2023 | 08-17-2023 | heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 577 bags | Class II | Terminated |
| 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-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-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-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-1126-2023 | 08-17-2023 | PHENYLephrine added to 0.9% sodium chloride, 20mg/250ml (80 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 297 bags | Class II | Terminated |
| D-1123-2023 | 08-17-2023 | CARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 16 bags | Class II | 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-1110-2023 | 08-17-2023 | CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 84 bags | Class II | Terminated |
| D-1111-2023 | 08-17-2023 | Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 100 bags | Class II | Terminated |
| D-1117-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 104 bags | Class II | Terminated |
| D-1125-2023 | 08-17-2023 | PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 586 bags | Class II | Terminated |
| D-1122-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 108 bags | Class II | Terminated |
| D-1136-2023 | 08-17-2023 | vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 477 bags | Class II | Terminated |
| D-1134-2023 | 08-17-2023 | oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 298 bags | Class II | Terminated |
| D-1132-2023 | 08-17-2023 | oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 1,996 bags. | Class II | Terminated |
| D-1112-2023 | 08-17-2023 | Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 786 Bags | Class II | Terminated |
| D-1115-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 40 bags | Class II | Terminated |
| D-1109-2023 | 08-17-2023 | CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 84 bags | Class II | Terminated |
| D-1133-2023 | 08-17-2023 | oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 2643 bags | Class II | Terminated |
| D-1137-2023 | 08-17-2023 | dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 235 bags | Class II | Terminated |
| D-1121-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 92 bags | Class II | Terminated |
| D-1119-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 136 bags | Class II | Terminated |
| D-1127-2023 | 08-17-2023 | PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 292 bags | Class II | Terminated |
| D-1131-2023 | 08-17-2023 | EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 554 bags | Class II | Terminated |
| D-1116-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 200 bags | Class II | Terminated |
| D-1108-2023 | 08-17-2023 | CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 184 | Class II | Terminated |
| D-1118-2023 | 08-17-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1 | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 140 bags | Class II | Terminated |
| D-1129-2023 | 08-17-2023 | EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1. | Lack of Assurance of Sterility:Lack of validation data for sanitization cycles | Central Admixture Pharmacy Services, Inc. / 340 bags | Class II | Terminated |
