Drugs Recalls

FDA Drug Class II Terminated

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

August 17, 2023 Central Admixture Pharmacy Services, Inc. 477 bags units

FDA Drug Class II Terminated

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.

August 17, 2023 Central Admixture Pharmacy Services, Inc. 554 bags units

FDA Drug Class II Terminated

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.

August 17, 2023 Central Admixture Pharmacy Services, Inc. 340 bags units

FDA Drug Class II Terminated

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

August 17, 2023 Central Admixture Pharmacy Services, Inc. 92 bags units

FDA Drug Class II Terminated

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

August 17, 2023 Central Admixture Pharmacy Services, Inc. 577 bags units

FDA Drug Class II Terminated

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:

August 17, 2023 Central Admixture Pharmacy Services, Inc. 200 bags units

FDA Drug Class II Terminated

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

August 17, 2023 Central Admixture Pharmacy Services, Inc. 340 bags units

FDA Drug Class II Terminated

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:

August 17, 2023 Central Admixture Pharmacy Services, Inc. 40 bags units

FDA Drug Class II Terminated

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 A

August 17, 2023 Central Admixture Pharmacy Services, Inc. 136 bags units

FDA Drug Class II Terminated

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, Pheo

August 17, 2023 Central Admixture Pharmacy Services, Inc. 84 bags units

FDA Drug Class II Terminated

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 43

August 17, 2023 Central Admixture Pharmacy Services, Inc. 132 bags units

FDA Drug Class III Completed

Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65

August 17, 2023 Lundbeck LLC 10,543 cartons units

FDA Drug Class II Terminated

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

August 17, 2023 Central Admixture Pharmacy Services, Inc. 2643 bags units

FDA Drug Class II Terminated

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.

August 17, 2023 Central Admixture Pharmacy Services, Inc. 297 bags units

FDA Drug Class II Terminated

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.

August 17, 2023 Central Admixture Pharmacy Services, Inc. 586 bags units

FDA Drug Class II Terminated

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

August 17, 2023 Central Admixture Pharmacy Services, Inc. 235 bags units

FDA Drug Class II Terminated

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,

August 17, 2023 Central Admixture Pharmacy Services, Inc. 108 bags units

FDA Drug Class II Terminated

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-

August 17, 2023 Central Admixture Pharmacy Services, Inc. 16 bags units

FDA Drug Class III Completed

Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03

August 16, 2023 Esperion 45,240 bottles units

FDA Drug Class II Terminated

NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.

August 15, 2023 TMC Acquisitions LLC dba Tailor Made Compounding 99 vials units

FDA Drug Class II Terminated

Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.

August 15, 2023 TMC Acquisitions LLC dba Tailor Made Compounding 9 vials units

FDA Drug Class III Ongoing

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, Manufactu

August 14, 2023 Glenmark Pharmaceuticals Inc., USA 1,200 bottles units

FDA Drug Class III Completed

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.

August 14, 2023 Baxter Healthcare Corporation 13,502 vials units

FDA Drug Class II Ongoing

All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.

August 14, 2023 Inmar Supply Chain Solutions, LLC Unknown units

FDA Drug Class III Terminated

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(U

August 14, 2023 Caplin Steriles Limited 19, 820 vials units

FDA Drug Class II Terminated

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

August 11, 2023 AVKARE LLC 35,184 cartons units

FDA Drug Class II Terminated

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

August 11, 2023 Baxter Healthcare Corporation 22,112 bags units

FDA Drug Class II Terminated

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 P

August 11, 2023 AVKARE LLC 35,184 tubes units

FDA Drug Class II Terminated

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

August 11, 2023 Baxter Healthcare Corporation a) 44,520; b) 60,762; c) 483,912 units

FDA Drug Class III Terminated

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.

August 10, 2023 Imprimis NJOF, LLC 2,683 bottles units

FDA Drug Class II Terminated

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),

August 10, 2023 Colgate Palmolive Company 182,046 tubes units

FDA Drug Class II Completed

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

August 9, 2023 Ecometics, Inc. a) 5028 bottles; b) 9809 bottles units

FDA Drug Class II Completed

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, Ma

August 9, 2023 Ecometics, Inc. a) 6,120 tubes, b) 540 tubes units

FDA Drug Class II Completed

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, Le

August 9, 2023 Ecometics, Inc. a) 9816 bottles; b) 10,776 bottles units

FDA Drug Class II Completed

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.

August 9, 2023 Ecometics, Inc. 32,583 bottles units

FDA Drug Class II Completed

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

August 9, 2023 Ecometics, Inc. 38,486 vials units

FDA Drug Class II Completed

AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.

August 9, 2023 Ecometics, Inc. 92,967 vials units

FDA Drug Class II Completed

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, Distribute

August 9, 2023 Ecometics, Inc. a) 52,879 bottles; b) 12,054 bottles units

FDA Drug Class III Terminated

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, M

August 7, 2023 Advanced Accelerator Applications USA, Inc. 10 units

FDA Drug Class I Ongoing

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

August 3, 2023 APG SEVEN, INC 120 bottles units

FDA Drug Class II Terminated

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,

August 2, 2023 Parker Laboratories, Inc. 9 units

FDA Drug Class II Terminated

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 El

August 2, 2023 Parker Laboratories, Inc. 50 units

FDA Drug Class II Terminated

Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93

August 2, 2023 Aurobindo Pharma USA Inc 9,890 bottles units

FDA Drug Class III Terminated

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

August 2, 2023 B. Braun Medical Inc 43,812 bags units

FDA Drug Class II Terminated

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 3

August 2, 2023 Parker Laboratories, Inc. 250 units

FDA Drug Class II Terminated

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,

August 2, 2023 Parker Laboratories, Inc. 8 units

FDA Drug Class II Terminated

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,

August 2, 2023 Parker Laboratories, Inc. 40 units

FDA Drug Class III Ongoing

Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05

July 27, 2023 ALEMBIC PHARMACEUTICALS, INC. 82,400 bottles units

FDA Drug Class II Terminated

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-

July 21, 2023 Aurobindo Pharma USA Inc 48 bottles units

FDA Drug Class II Completed

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 Corp

July 21, 2023 The Ritedose Corporation 44 cartons units