Drug and pharmaceutical recalls
17658 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2024-03-20FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIBicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10
cGMP Deviations: Products were stored outside the drug label specifications.
- 2024-03-20FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIInfuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
cGMP Deviations: Products were stored outside the drug label specifications.
- 2024-03-20FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIRocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10
cGMP Deviations: Products were stored outside the drug label specifications.
- 2024-03-20FDA-DrugB. Braun Medical IncClass IIPotassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
- 2024-03-20FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIFebuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-03-20FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIFebuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-03-13FDA-DrugStason Pharmaceuticals, Inc.Class IIIMercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
Failed Dissolution Specifications: results slightly under spec at at 9-months.
- 2024-03-13FDA-DrugEugia US LLCClass IIMethylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01
Failed Dissolution Specifications
- 2024-03-13FDA-DrugContract Pharmaceuticals Limited CanadaClass IIIClindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- 2024-03-13FDA-DrugContract Pharmaceuticals Limited CanadaClass IIIClindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
- 2024-03-06FDA-DrugDenver Solutions, LLC DBA Leiters HealthClass IILidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- 2024-03-06FDA-DrugDenver Solutions, LLC DBA Leiters HealthClass IIMoxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- 2024-03-06FDA-DrugDenver Solutions, LLC DBA Leiters HealthClass IIMoxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
- 2024-03-06FDA-DrugSeatex LLCClass IIPROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- 2024-03-06FDA-DrugSeatex LLCClass II7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- 2024-03-06FDA-DrugSeatex LLCClass II7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- 2024-03-06FDA-DrugSeatex LLCClass IIPROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- 2024-03-06FDA-DrugSeatex LLCClass IIPROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
- 2024-03-06FDA-DrugBausch Health Companies, Inc.Class IIOmeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.
Subpotent Drug: Out of specification for assay
- 2024-03-06FDA-DrugBrassica Pharma Pvt LtdClass IILubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356
Lack of Assurance of Sterility
- 2024-03-06FDA-DrugBrassica Pharma Pvt LtdClass IICVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141
Lack of Assurance of Sterility
- 2024-03-06FDA-DrugBrassica Pharma Pvt LtdClass IIEquate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304
Lack of Assurance of Sterility
- 2024-03-06FDA-DrugBrassica Pharma Pvt LtdClass IIEquate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298
Lack of Assurance of Sterility
- 2024-03-06FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIMesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.
Failed Dissolution Specifications: Out of specification for dissolution.
- 2024-03-06FDA-DrugGolden State Medical Supply Inc.Class IIFluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
- 2024-02-28FDA-DrugMicro Labs LimitedClass IIClobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01
CGMP Deviations: Out of specification for residual solvents.
- 2024-02-28FDA-DrugMCKESSON CORPORATIONClass IICABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
- 2024-02-28FDA-DrugInsight Pharmaceuticals LLC, a Prestige Consumer Healthcare companyClass ITING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3
Chemical Contamination; presence of benzene.
- 2024-02-28FDA-DrugToday The WorldClass IArize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
- 2024-02-28FDA-DrugToday The WorldClass ISCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
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