FDA recalls: June 2019
Every food and drug recall report the FDA published in June 2019: 193 reports, 23 of them Class I.
- Recall reports
- 193
- Class I (serious)
- 23
- Food
- 74
- Drugs
- 119
- Jun 26, 2019Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Release…Drug · Sun Pharmaceutical Industries, Inc.Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limitClass II
- Jun 26, 2019Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended Releas…Drug · Sun Pharmaceutical Industries, Inc.Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limitClass II
- Jun 26, 2019Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Release Tablets…Drug · Sun Pharmaceutical Industries, Inc.Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limitClass II
- Jun 26, 2019Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Release Tablets,…Drug · Sun Pharmaceutical Industries, Inc.Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limitClass II
- Jun 26, 2019Betamethasone Dipropionate Ointment USP, 0Drug · Teligent Pharma, Inc.Failed Impurities/Degradation SpecificationsClass III
- Jun 26, 2019Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules contai…Drug · Akorn IncLabeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.Class III
- Jun 26, 2019QUIK-CARE Aerosol Foam Hand Sanitizer (62Drug · Ecolab IncIncorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.Class III
- Jun 26, 2019Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Package…Drug · American Health PackagingGMP Deviations: Potential cross contamination due to cleaning procedure failure.Class II
- Jun 26, 2019Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Glut…Drug · P & L Developments, LLCcGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepaci…Class II
- Jun 26, 2019Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Fl…Drug · P & L Developments, LLCcGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepaci…Class II
- Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dy…
- Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr,…
- ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare…
- Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila H…
- Pramipexole Dihydrochloride Tablets 0
- Pramipexole DihydrochlorideTablets 0
- Pramipexole Dihydrochoride Tablets 0
- Pramipexole Dihydrochloride Tablets 0
- Pramipexole Dihydrochloride Tablets 0
- Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Ca…
- MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila He…
- MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in…
- MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Hea…
- MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Hea…
- Pramipexole Dihydrochloride Tablets 1
- MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Heal…
- Regal's Fundraising Cookies: Chocolate Chip flavor
- Regal's Fundraising Cookies: Cornflake flavor
- Regal's Fundraising Cookies: Shortbread flavors
- 30 Lbs IQF Wild Blueberries, Keep Frozen -10*C
- Maglio Companies Jalapeno Peppers sold in the following sized packages: 10 lb
- National Heartland Naturals Premium Quality Pearl Barley 32 oz Plastic Bag
- R.H. Macy & Co. Milk Chocolate Covered Peanut Butter Pretzels, 8 oz 1 unit per packag…
- R.H. Macy & Co. Milk Chocolate Covered Pecan Caramel Clusters, 7oz 1 unit per package,…
- R.H. Macy & Co. Dark Chocolate Sea Salt Caramels, 7 oz. 1 unit per package, oval metal…
- R.H. Macy & Co. Milk Chocolate Butter Almond Toffee, 6 oz. 1 unit per package, oval me…
- 365 by Whole Foods Market Classic Potato Salad packaged in a clear plastic clamshell 8 Oz
- 365 by Whole Foods Market Classic Tuna Salad Wrap packaged in a clear cellophane 7
- 365 by Whole Foods Market Smoked Mozzarella Pasta Salad packaged in a clear plastic cla…
- 365 by Whole Foods Market Traditional Egg Salad packaged in a clear plastic clamshell 9 Oz
- 365 by Whole Foods Yellowfin Tuna Salad packaged in a clear plastic clamshell 8 Oz
- Veggie Crudite Bowl with Asparagus and Bell Peppers packaged in a Clear plastic bowl 34
- Veggie Crudite Bowl with Jicama and Mini Peppers packaged in a Clear plastic bowl 34
- Ben & Jerry s Coconut Seven Layer Bar Bulk
- Ben & Jerry s Chunky Monkey
- Immuno PRP Spray
- Viralox, UPC 8 63784 00015 0. Immune Balancing Ploypeptide Oral Spray. 5.0 fl. oz. (15…
- DPS Throat Spray
- Immulox, UPC 1 82863 000064 6. Immune Balance Polypeptide Supplement with Naturally Occ…
- Marine Harvest USA, Contains Fish: Atlantic Salmon, Premium 35 lbs, Product must be coo…
- MONAKA BELGIUM CHOCO & KURUMI DAIICHI F, 2
- Bobbie Milk-Based Powder Companion Formula Net Wt
- Basil Pesto, sold by weight in plastic deli containers PLU code beginning with 255926
- Sun-dried tomato pesto, sold by weight in plastic deli containers PLU code beginning w…
- Pasteurized donor human breast milk, Pool 9029, Batch 1 packaged in 3 ounce (90 cc) pla…
- Bacteriostatic Water for Injection, 10 mL vials, Pharm D
- B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthe…
- Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D
- Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D
- Human Chorionic Gonadotropin 12,000 IU vials Pharm D
- Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D
- Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline…
- Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D
- Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D
- Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D
- Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D
- Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D
- Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D
- Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D
- Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D
- Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D
- Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D
- Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprost…
- Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with dispo…
- ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distr…
- Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by:…
- Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Inject…
- Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24…
- RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle
- Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin…
- Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12
- Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspi…
- Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl
- Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/…
- Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10…
- Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl,…
- Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant, One Pint…
- Nasal Decongestant Spray Regular, Oxymetazoline HCl 0
- Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg),…
- Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant,…
- Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton
- Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL
- Hyoscyamine Oral Drops 0
- Hyoscyamine Sulfate Elixir 0
- Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD
- Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufact…
- Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 m…
- Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codei…
- Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) bottle
- Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol f…
- Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongest…
- Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectoran…
- Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per…
- Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12
- Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl
- Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL
- Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL
- Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz
- Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL
- Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12…
- Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton
- Hemorrhoidal Suppositories (Phenylephrine HCl 0
- Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0
- Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL…
- Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL b…
- RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle
- Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1
- Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1
- Bisacodyl Suppositories, Brite Stock, Reese
- Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC…
- Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trisp…
- Lotemax (loteprednol etabonate ophthalmic gel 0
- PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by…
- AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd
- Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc
- Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc
- Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temper…
- Sulfur Colloid Reaction Vial 1
- Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthet…
- Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetop…
- Sn-Tetrofosmin Kit 5
- Sn-Pyrophosphate Kit, 11
- Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter…
- Senna (sennosides 8
- Senna (sennosides 8
- 7-Eleven The Italian Job refrigerated sandwich, clear plastic overwrap net wt
- Cool Haus Awesome Dessert - Dairy Free Horchata Frozen Dessert Sandwich
- Izzio Artisan Bakery 100% Rye Bread
- CHOCOLATE MILK CHOCOLATE MEIJI, 1
- CHOCOLATE BLACK CHOCOLATE MEIJI, 1
- CHOCOLATE ALMOND CHOCOLATE MEIJI, 3
- CHOCOLATE MACADAMIA MEIJI, 2
- CHOCOLATE KINOKO NO YAMA MEIJI, 2
- CHOCOLATE TAKENOKO NO SATO MEIJI (Chocolate wheat snack, 2
- CHOCOLATE CHOCO BABY (S) MEIJI, 1
- Performance Mushrooms product is dried mushroom blend of 4 different mushroom mycelial…
- Park Street Deli, Hummus and Veggies, Classic Hummus, Carrots & Celery NET WT 5 OZ (142g)
- Topnotch Foods Natural Bread Crumbs: 50 lb
- Topnotch Foods Italian Bread Crumbs: 10 lb
- 10.5 " Flat Edge Pizza Crust, packaged in a box with 40 pieces per box
- Bacon Shallot Potato Salad, internal item PLU code 52365, sold as bulk from the full se…
- Gia Russa Whole Grain Italian Unseasoned Bread Crumbs in 10 Oz Paperboard Canisters
- Gia Russa Whole Grain Italian Seasoned Bread Crumbs in 10 Oz Paperboard Canisters
- Strawberry Banana Smoothie, 3
- Art Cream Gluten Free Cookies & Cream ice cream, one pint
- Young Ocean brand Seasoned Alaskan Pollock Roe, frozen, wrapped in plastic liner and pa…
- Bevacizumab 2
- ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap…
- AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0
- Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant W…
- INODERM Antiseptic Hand Soap (E-2),
- INOFOAM Foaming E-2 Food Handling Wash with
- Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Ant…
- Mild Health Care Antibacterial Hand Soap,
- Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 m…
- Antibacterial Hand Soap,
- Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan,…
- Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle,…
- The Beast, The Beast can be taken under the situation of Heart disease and even after d…
- purely elizabeth Coconut Cashew Grain-Free Granola, packaged in Net Wt
- purely elizabeth Banana Nut Butter Grain-Free Granola
- purely elizabeth Banana Nut Butter Grain-Free Bar
- purely elizabeth Chocolate Sea Salt Grain-Free Bar
- purely elizabeth Peanut Butter Grain-Free Bar
- purely elizabeth Coconut Cashew Grain-Free Bar
- purely elizabeth Pumpkin Spice + Ashwagandha Grain-Free Granola
- GreenWise Cranberry Cashew Granola
- GreenWise Cinnamon Peanut Butter Grain-Free Granola
- Specially Selected Paleo Granola, Grain Free
- Fiddyment Farms Fiddy Fire In-Shell Pistachios 2
- First Street Dark Chocolate Nonpareils
- Biscotti-Plain
- Dole Classic Coleslaw (US) Shredded cabbage and carrots
- Dole Colourful Coleslaw ( Salade Chou Coloree) - Canada Shredded green and red cabbag…
- Biltmore, Sashimi Grade Smoked Wild Sockeye All Natural Alaskan Salmon, 4 oz
- Global Pride Rattan Shoots in Brine: 24 oz
- Colby Jack Cheese in 40 pound and 640 pound blocks
- Suja Organic Kombucha - Ginger Lemon: 15
- Suja Organic Kombucha - Peach Ginger: 15
- Suja Organic Kombucha - Mixed Berries: 15
- Suja Organic Kombucha - Variety Pack: 6 x 15
- Wegman's Neptune Salad 1 lb containers, UPC Begins with 2010883100000, Model/catalog…
- Laxmi Brand Dried Apricot 7 oz (200g) Plastic Pouch UPC Code: 2324617054
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