Recall
Get alerts

All recalls8,521 total

K
Keystone Industries — Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford R

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

A
Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pha

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

K
Keystone Industries — safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

K
Keystone Industries — Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com.

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

L
LNK International, Inc. — Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 m

CGMP Deviations: Released product should have been rejected.

K
Keystone Industries — Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

K
Keystone Industries — Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Z
Zydus Pharmaceuticals (USA) Inc — Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distribu

Labeling: Not Elsewhere Classified - Wrong NDC number

K
Keystone Industries — Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

K
Keystone Industries — M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

K
Keystone Industries — Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

M
MXBBB — UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323

cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.

A
Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laborat

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

K
Keystone Industries — Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

K
Keystone Industries — Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 Mendota Heights Road, Saint P

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

S
Stuyvers Bread (Premium Brand Bakery Division) — Baguette, Artisan Multigrain. (30 Units/box) 400g/each. Contains: Wheat, Sesame Seeds, Gluten (rye, barley, oat) Lot#24313

Possible contamination by a foreign object (metal) in sub-ingredient in dinner roll product

S
Stuyvers Bread (Premium Brand Bakery Division) — Pull apart Holiday Rolls (cluster bun). (2 Units/bag) 195g/each. Contains: Wheat, Milk Lot#24312

Possible contamination by a foreign object (metal) in sub-ingredient in dinner roll product

B
Brands International Corporation — Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3

CGMP Deviations: lack of adequate release testing.

G
Gilster-Mary Lee Corporation Cake Plant — Bowl & Basket onion soup and dip mix, net wt 2 oz (2-1oz pouches), UPC 041190083947, Distributed by: Wakefern Food Corp, 5000 Riverside Drive, Keasbey, NJ 088

Undeclared egg

H
House Of Flavors, Inc. — Giant Eagle churned Butter Pecan Reduced Fat 48FLOZ, UPC 030034940430; 6 retail units per case

Undeclared soy (soy lecithin).

A
American Regent, Inc. — Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Ca

Presence of Particulate Matter: Potential for glass delamination from the vials.

A
American Regent, Inc. — Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical

Presence of Particulate Matter: Potential for glass delamination from the vials.

S
Safecor Health, LLC — Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

S
Safecor Health, LLC — Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

S
Safecor Health, LLC — Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

A
American Regent, Inc. — Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11

Presence of Particulate Matter: Potential for glass delamination from the vials.

S
Safecor Health, LLC — Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

S
Safecor Health, LLC — Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

C
Compass Minerals America Inc. — Bulk salt product shipped in 1 metric ton tote; 50lb bag Special Purity Granulated Food-Grade Salt with UPC 041582150158; 44lb bag sifto Hy Grade Food Grade Salt, Compa

foreign material

W
Wegmans Food Markets, Inc. — Wegmans Large Asian Sesame Salad with Chicken and Asian Peanut Dressing.

Contains undeclared egg

A
ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmace

Subpotent drug

C
Cumberland Packing Corp. — Organic Hot Agave in the Raw, 10 oz.

Elevated Osmophilic Yeast Count

A
Aurobindo Pharma USA Inc — Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

T
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapoli

Failed Impurity/Degradation Specifications

A
Aurobindo Pharma USA Inc — Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma US

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

T
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapol

Failed Impurity/Degradation Specifications

A
Aurobindo Pharma USA Inc — Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma US

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

A
Armonia Natural Store LLC — OneMultivitaminic GAF-PLUS Advance 300ml, plastic bottle, Room Temperature

Contains undeclared drugs Acetaminophen and Dexamethasone Phosphate, and the undeclared sweetener Aspartame

M
Midlab Incorporated — ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139

cGMP Deviations: Out of specification results for micro in hand soap products.

M
Midlab Incorporated — Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509

cGMP Deviations: Out of specification results for micro in hand soap products.

T
Tailstorm Health INC — BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1

Lack of Sterility Assurance

M
Midlab Incorporated — boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015

cGMP Deviations: Out of specification results for micro in hand soap products.

M
Midlab Incorporated — Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670

cGMP Deviations: Out of specification results for micro in hand soap products.

M
Midlab Incorporated — Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339

cGMP Deviations: Out of specification results for micro in hand soap products.

T
Trinity Gold Nutrition — Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.

M
Midlab Incorporated — MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303

cGMP Deviations: Out of specification results for micro in hand soap products.

N
NESTLE HEALTH SCIENCE — Nestle Health Services Nutren 2.0 kCal/mL, Calorically Dense Complete Nutrition with Fiber Unflavored. 1000mL (1.1QT). UPC 0 43900-18181 3. Manufactured for Nestle HealthCar

Labeling Error. Nutren 2.0 UltraPak pouches were mislabeled with an Isosource 1.5 label.

P
Pero Family Farms Food Company LLC — Pero Family Farms Squash Sliced Zucchinni & Yellow Squash, Net Wt. 11oz (311g) Plastic Tray, 4 trays per carton, Microwavable Tray, Keep Refrigerated. UPC 87489600

Squash products potentially contaminated with Listeria monocytogenes.

P
Piazza Produce (dba CIBUS Fresh) — CIBUS Fresh, Jack & Olive, Sprig and Sprout branded Autumn Turkey Sandwich 9.65oz UPC 00810028251915

Spreadable brie, 2/3lb used in sandwich was recalled by manufacturer due to possible Listeria monocytogenes contamination

L
Las Delicias Distributors, LLC — El Gallo Jalape¿o Queso salsa

Product does not include statement: Contains milk

← Previous

Page 151 of 171

Next →