Drug and pharmaceutical recalls
17622 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2023-09-27FDA-DrugAMMAN PHARMACEUTICAL INDUSTRIESClass IITRP 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
- 2023-09-20FDA-DrugHua Da Trading, Inc. dba Wefun Inc.Class IWEFUN 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.
- 2023-09-20FDA-DrugVistaPharm LLCClass IISucralfate 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
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
- 2023-09-20FDA-DrugBE PHARMACEUTICALS AGClass IIPantoprazole 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.
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
- 2023-09-13FDA-DrugMarlex Pharmaceuticals, Inc.Class IIDigoxin 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.
- 2023-09-13FDA-DrugMarlex Pharmaceuticals, Inc.Class IDigoxin 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.
- 2023-09-13FDA-DrugAVKARE LLCClass IICapsaicin 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
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
- 2023-09-13FDA-DrugAVKARE LLCClass IISodium 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
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
- 2023-09-13FDA-DrugAscend Laboratories, LLCClass IIIFosfomycin 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
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
- 2023-09-13FDA-DrugCaplin Steriles LimitedClass IIIMilrinone 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
Failed Impurities/Degradation Specifications
- 2023-09-13FDA-DrugEsperionClass IIINexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03
Failed dissolution specifications: below specification results at stability 12-month
- 2023-09-06FDA-DrugAPG SEVEN, INCClass IVegetal 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.
- 2023-09-06FDA-DrugLundbeck LLCClass IIISabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
Cross contamination with other products
- 2023-09-06FDA-DrugBaxter Healthcare CorporationClass IIDianeal 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
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- 2023-09-06FDA-DrugBaxter Healthcare CorporationClass IIDIANEAL 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.
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- 2023-09-06FDA-DrugContract Pharmaceuticals Limited CanadaClass IIIClindamycin 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
Defective Container: slow leakage under the cap
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIdilTIAZem 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
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIdilTIAZem 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
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIvancomycin 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
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIheparin 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
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIoxyTOCIN, 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
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIoxyTOCIN 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
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIoxyTOCIN 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
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIEPINEPHrine 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
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIEPINEPHrine 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
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIEPINEPHrine, 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
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIPHENYLephrine 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
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIPHENYLephrine, 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
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIPHENYLephrine 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
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIPHENYLephrine, 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
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