Product Recalls in 2023

FDA Drug Class II Ongoing

Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25

May 2, 2023 Apollo Care, LLC 682 bags units

FDA Drug Class II Ongoing

FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25

May 2, 2023 Apollo Care, LLC 308 bags units

NHTSA Ongoing

Condensation Pan Overflow May Cause Fire

May 2, 2023 TIFFIN MOTORHOMES, INC. 231 units

FDA Drug Class II Ongoing

VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25

May 2, 2023 Apollo Care, LLC 1622 bags units

FDA Drug Class II Ongoing

FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-910-25

May 2, 2023 Apollo Care, LLC 790 syringes units

FDA Drug Class II Ongoing

Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05

May 2, 2023 Apollo Care, LLC 2040 syringes units

FDA Drug Class II Ongoing

Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-020-05

May 2, 2023 Apollo Care, LLC 90 syringes units

FDA Drug Class II Ongoing

VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25

May 2, 2023 Apollo Care, LLC 1113 bags units

NHTSA Ongoing

Inoperative Horn Button

May 2, 2023 MACK TRUCKS, INC 5 units

FDA Drug Class II Ongoing

VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50

May 2, 2023 Apollo Care, LLC 240 bags units

NHTSA Ongoing

High-Voltage Battery Software Error/FMVSS 305

May 2, 2023 MERCEDES-BENZ USA, LLC. 3,828 units

FDA Drug Class II Ongoing

VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-255-25

May 2, 2023 Apollo Care, LLC 491 bags units

FDA Drug Class II Ongoing

VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50

May 2, 2023 Apollo Care, LLC 2040 bags units

FDA Drug Class II Ongoing

VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25

May 2, 2023 Apollo Care, LLC 646 bags units

FDA Drug Class II Ongoing

VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-264-25

May 2, 2023 Apollo Care, LLC 1113 bags units

FDA Drug Class II Terminated

Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.

May 1, 2023 Glenmark Therapeutics, Inc. 19,968 bottles units

FDA Drug Class II Terminated

LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268

May 1, 2023 RemedyRepack Inc. 9,038 vials units

NHTSA Ongoing

Replacement Air Bag Inflator Incorrectly Installed

May 1, 2023 FORD MOTOR COMPANY 231,942 units

NHTSA Ongoing

Generator Set Fuel Hose May Cause Gas Leak

May 1, 2023 WINNEBAGO INDUSTRIES, INC. 6,536 units

FDA Drug Class II Ongoing

Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-2534-00, MFG: Akorn, Lake Forest, IL 60045, Repackaged by : RemedyRepack Inc., PA

May 1, 2023 RemedyRepack Inc. 29 x 30-count card, 1 x 100 UD box units

FDA Drug Class II Ongoing

Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10

May 1, 2023 RemedyRepack Inc. 12 5mL bottles units

FDA Food Class II Terminated

Copitas; small ceramic cups; "Del Maguey" embossed on the bottom; distributed by Del Maguey

May 1, 2023 Pernod Ricard Usa Inc 177,000 copitas units

FDA Food Class II Terminated

Top Label: TRADER JOE'S GENOVA PESTO NET WT. 7 OZ. (198g) Side Label: TRADER JOE'S HUMMUS DIP NET WT. 7 OZ (98g) CONTAINS: SESAME. DIST. & SOLD EXCLUSIVELY BY: TRADER JOE'S, MONROVIA, CA 91016 UPC 001

May 1, 2023 Bakkavor Foods USA Inc. 290cs/24/7 oz cups units

FDA Drug Class II Terminated

potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6060-1.

April 28, 2023 Central Admixture Pharmacy Services, Inc. 9432 bags units

FDA Drug Class II Terminated

Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8077-1, code 7128580771.

April 28, 2023 Central Admixture Pharmacy Services, Inc. 3165 bags units

NHTSA Ongoing

Rearview Image May Not Display/FMVSS 111

April 28, 2023 FORD MOTOR COMPANY 523 units

FDA Drug Class II Terminated

oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6044-1.

April 28, 2023 Central Admixture Pharmacy Services, Inc. 104807 bags units

FDA Drug Class II Terminated

Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 1

April 28, 2023 Central Admixture Pharmacy Services, Inc. 140 bags units

FDA Drug Class II Terminated

PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 7128

April 28, 2023 Central Admixture Pharmacy Services, Inc. 5304 bags units

FDA Drug Class II Terminated

Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781.

April 28, 2023 Central Admixture Pharmacy Services, Inc. 3326 bags units

FDA Drug Class II Terminated

vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6176

April 28, 2023 Central Admixture Pharmacy Services, Inc. 11338 bags units

FDA Drug Class II Terminated

Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allent

April 28, 2023 Central Admixture Pharmacy Services, Inc. 325 bags units

FDA Drug Class II Terminated

heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 712

April 28, 2023 Central Admixture Pharmacy Services, Inc. 5207 bags units

FDA Drug Class II Terminated

oxyTOCIN 20 units added to Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6038-1.

April 28, 2023 Central Admixture Pharmacy Services, Inc. 14362 bags units

FDA Drug Class II Terminated

Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown,

April 28, 2023 Central Admixture Pharmacy Services, Inc. 52 bags units

FDA Drug Class II Terminated

tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2.

April 28, 2023 Central Admixture Pharmacy Services, Inc. 225 syringes units

FDA Drug Class II Terminated

oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.

April 28, 2023 Central Admixture Pharmacy Services, Inc. 3865 bags units

NHTSA Ongoing

Instrument Cluster Display Screen May Freeze

April 28, 2023 LORDSTOWN EV CORP 5 units

FDA Drug Class II Terminated

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA

April 28, 2023 Central Admixture Pharmacy Services, Inc. 71 bags units

FDA Drug Class II Terminated

Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown,

April 28, 2023 Central Admixture Pharmacy Services, Inc. 350 bags units

FDA Drug Class II Terminated

Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-

April 28, 2023 Central Admixture Pharmacy Services, Inc. 255 bags units

FDA Drug Class II Terminated

Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106

April 28, 2023 Central Admixture Pharmacy Services, Inc. 269 bags units

FDA Drug Class II Terminated

PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285

April 28, 2023 Central Admixture Pharmacy Services, Inc. 6407 bags units

FDA Drug Class II Terminated

Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106

April 28, 2023 Central Admixture Pharmacy Services, Inc. 544 bags units

FDA Drug Class II Terminated

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdri

April 28, 2023 Central Admixture Pharmacy Services, Inc. 747 bags units

FDA Drug Class II Terminated

vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown,

April 28, 2023 Central Admixture Pharmacy Services, Inc. 4259 bags units

FDA Drug Class II Terminated

vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1.

April 28, 2023 Central Admixture Pharmacy Services, Inc. 13772 bags units

FDA Drug Class II Terminated

vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7

April 28, 2023 Central Admixture Pharmacy Services, Inc. 8252 bags units

FDA Drug Class II Terminated

Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allen

April 28, 2023 Central Admixture Pharmacy Services, Inc. 613 bags units

FDA Drug Class II Terminated

Cardioplegia Solution, Maintenance 4:1 Plasmalyte, low potassium, low K, packaged in 1047 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown,

April 28, 2023 Central Admixture Pharmacy Services, Inc. 226 bags units