Drugs Recalls

FDA Drug Class II Terminated

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-

July 21, 2023 Aurobindo Pharma USA Inc 48 bottles units

FDA Drug Class II Terminated

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, 7

July 20, 2023 SCA Pharmaceuticals 183 bags units

FDA Drug Class III Terminated

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 Pha

July 18, 2023 Sun Pharmaceutical Industries Inc. 360 60-count bottles units

FDA Drug Class III Terminated

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, N

July 18, 2023 Ascend Laboratories LLC 99,516 sachets units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 2,082 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 1,216 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 1669 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 8,942 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 150 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 2,340 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 10,065 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 1,389 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 2,077 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 723 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 1,044 bags units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 621 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 5,124 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 94 bags units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 3824 bags units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 848 bags units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 10,494 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 12,239 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 1,699 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 6,770 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 1,235 syringes units

FDA Drug Class II Terminated

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 Dunbroo

July 17, 2023 Central Admixture Pharmacy Services, Inc. 295 bags units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 1,197 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 19,014 bags units

FDA Drug Class II Terminated

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.

July 17, 2023 Central Admixture Pharmacy Services, Inc. 2,640 Syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 81,073 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 2,228 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 8,146 bags units

FDA Drug Class II Terminated

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 Dunbro

July 17, 2023 Central Admixture Pharmacy Services, Inc. 1,486 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 2,389 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 9,517 syringes units

FDA Drug Class II Terminated

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 D

July 17, 2023 Central Admixture Pharmacy Services, Inc. 1,114 bags units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 5,259 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 100 syringes units

FDA Drug Class II Terminated

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,

July 17, 2023 Central Admixture Pharmacy Services, Inc. 896 bags units

FDA Drug Class II Terminated

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: 71286-20

July 17, 2023 Central Admixture Pharmacy Services, Inc. 2,717 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 16,971 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 2,994 syringes units

FDA Drug Class II Terminated

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

July 17, 2023 Central Admixture Pharmacy Services, Inc. 720 syringes units

FDA Drug Class II Terminated

CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:

July 14, 2023 Central Admixture Pharmacy Services, Inc. 56 bags units

FDA Drug Class II Terminated

vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1

July 14, 2023 Central Admixture Pharmacy Services, Inc. 15,304 bags units

FDA Drug Class II Terminated

CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85

July 14, 2023 Central Admixture Pharmacy Services, Inc. 148 bags units

FDA Drug Class II Terminated

CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196

July 14, 2023 Central Admixture Pharmacy Services, Inc. 48 units

FDA Drug Class II Terminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, P

July 14, 2023 Central Admixture Pharmacy Services, Inc. 80 bags units

FDA Drug Class II Terminated

EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.

July 14, 2023 Central Admixture Pharmacy Services, Inc. 6,784 bags units

FDA Drug Class II Terminated

vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1

July 14, 2023 Central Admixture Pharmacy Services, Inc. 4824 bags units