Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-08-24FDA-DrugAire-Master of America IncClass IIProtect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- 2022-08-24FDA-DrugAire-Master of America IncClass IIStage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- 2022-08-24FDA-DrugAire-Master of America IncClass IIAvant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- 2022-08-24FDA-DrugAire-Master of America IncClass IIAvant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- 2022-08-24FDA-DrugNephron Sc IncClass IIKetorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
cGMP Deviations: deviations leading to potential cross-contamination.
- 2022-08-24FDA-DrugAkron Pharma, Inc.Class IIIAcetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
- 2022-08-24FDA-DrugAkron Pharma, Inc.Class IIIAcetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
- 2022-08-24FDA-DrugZydus Pharmaceuticals (USA) IncClass IIFulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.
Failed Impurities/Degradation Specifications
- 2022-08-24FDA-DrugAmerisource Health Services LLCClass IIIAzacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
Subpotent Drug
- 2022-08-24FDA-DrugBaxter Healthcare CorporationClass IIAcetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
- 2022-08-24FDA-DrugNephron Sterile Compounding Center LLCClass IIPF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- 2022-08-24FDA-DrugNephron Sterile Compounding Center LLCClass IIPF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- 2022-08-24FDA-DrugNephron Sterile Compounding Center LLCClass IITrisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- 2022-08-24FDA-DrugNephron Sterile Compounding Center LLCClass IIPF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- 2022-08-24FDA-DrugLupin Pharmaceuticals Inc.Class IIRifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
- 2022-08-24FDA-DrugMEDEK LLCClass IM Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC Code: 77797-001-01, Distributed by: Medek, LLC 315 E. Business Hwy 83 Alamo, TX 78516, NDC Code: 75432-001-02.
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
- 2022-08-24FDA-DrugHERON THERAPEUTICS, INC.Class IIIZynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
- 2022-08-17FDA-DrugTeva Pharmaceuticals USA IncClass IIIAzacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
- 2022-08-17FDA-DrugSterRx, LLCClass IIfentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
Lack of Assurance of Sterility
- 2022-08-17FDA-DrugSterRx, LLCClass IIFentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
Lack of Assurance of Sterility
- 2022-08-17FDA-DrugStrides Pharma Inc.Class IIPrednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
- 2022-08-17FDA-DrugAVKARE Inc.Class IIILamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
Labeling: Label Error on Declared Strength
- 2022-08-17FDA-DrugCIPLAClass IIDifluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Lack of Assurance of Sterility: Complaints received of defective container closure.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIAlcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 67777-300-01 (current NDC) NDC# 67777-120-10 (discontinued)
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IISterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIRacepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIAsthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIDakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIA&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIPataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01.
CGMP Deviations: products were stored outside the drug label specifications.
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