Product Recalls in 2021

3,955 recalls issued this year

219

CPSC

1,491

FDA Food

1,152

FDA Drug

1,093

NHTSA

FDA Drug Class II Terminated

TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Drug Class II Terminated

METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Drug Class II Ongoing

Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack

August 13, 2021 Pfizer Inc.
FDA Drug Class II Terminated

MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Drug Class II Terminated

MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Drug Class II Terminated

TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Drug Class II Terminated

LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Food Class II Terminated

BR SPECIAL ROLL SUPER SET 16PCL UPC:81282401203 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.

August 13, 2021 Mai Cuisine 103 packages - all products sold in New Leaf Market Stores units
FDA Drug Class II Terminated

ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Drug Class II Terminated

VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Drug Class II Terminated

Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05

August 13, 2021 Zydus Pharmaceuticals USA Inc 2880 bottles units
FDA Food Class II Terminated

Hamburger buns, customer specified formula, in unlabeled clear plastic bags, 30 or 12 buns per bag.

August 13, 2021 Kansas City LLC., DBA Best Harvest Bakeries 10,712 buns total units
FDA Food Class II Terminated

Potato buns, in unlabeled clear plastic bags, 30 or 12 buns per bag.

August 13, 2021 Kansas City LLC., DBA Best Harvest Bakeries 10,712 buns total units
FDA Food Class II Completed

Alfalfa Sprouts 12/4oz Plastic container, sold under the the brand names of: Sunny Creek UPC 7 38015 77740 1 SUNNY CREEK FARM Tryon, NC 28782 and BLOOMSBURY ORGANIC FARMKEEP REFRIGERATED

August 13, 2021 Sysco Atlanta, LLC 52/12/4oz Plastic container units
FDA Food Class II Terminated

12 PC Shrimp Tempura Kabuki Roll [WR UPC:81244803410 Products were sold from Genji Sushi counters inside Whole Foods Market stores

August 13, 2021 Mai Cuisine 1490 packages - all Genji products units
FDA Drug Class II Terminated

LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Food Class II Terminated

Spicy Shrimp Tempura Roll [WR] UPC: 81244803443 Products were sold from Genji Sushi counters inside Whole Foods Market stores

August 13, 2021 Mai Cuisine 11490 packages - all Genji products units
FDA Food Class II Terminated

12 PC Spicy Shrimp Tempura Roll [WR] UPC: 81244803385 Products were sold from Genji Sushi counters inside Whole Foods Market stores

August 13, 2021 Mai Cuisine 1490 packages, all Genji Products units
FDA Food Class II Terminated

SCORPION ROLL UPC:81282401138 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.

August 13, 2021 Mai Cuisine 103 packages - all products sold in New Leaf Market stores units
FDA Food Class II Terminated

Spicy Shrimp Inari 4 PC [WR] UPC: 81244803399 Products were sold from Genji Sushi counters inside Whole Foods Market stores

August 13, 2021 Mai Cuisine 1490 packages - all Genji products units
FDA Food Class II Terminated

Hamburger buns, 4" in unlabeled clear plastic bags, 30 or 12 buns per bag.

August 13, 2021 Kansas City LLC., DBA Best Harvest Bakeries 10,712 buns total units
FDA Food Class II Terminated

CHEF'S ASSORTED NIGIRI 6PC UPC: 81282401130 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.

August 13, 2021 Mai Cuisine 103 packages - all products sold in New Leaf Market stores. units
FDA Food Class II Terminated

Shrimp Summer Roll UPC:81282401393 Products were sold from Genji Sushi counters inside Whole Foods Market stores

August 13, 2021 Mai Cuisine 1490 packages - all Genji products units
FDA Drug Class II Terminated

CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Food Class II Terminated

Hostess Soft White Hamburger Buns, Net Wt. 12 OZ, UPC 888109110987

August 13, 2021 Hostess Brands, LLC 178,867 cases (total) units
FDA Drug Class II Terminated

MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Food Class II Terminated

Hamburger buns, 5" in unlabeled clear plastic bags, 30 or 12 buns per bag.

August 13, 2021 Kansas City LLC., DBA Best Harvest Bakeries 10,712 buns total units
FDA Drug Class II Terminated

Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Food Class II Terminated

Shrimp California Roll [WR] UPC: 81244803442 Products were sold from Genji Sushi counters inside Whole Foods Market stores

August 13, 2021 Mai Cuisine 1490 packages - all Genji Products units
FDA Drug Class II Terminated

Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4

August 13, 2021 SigmaPharm Laboratories LLC 1,993 bottles units
FDA Drug Class II Terminated

PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Food Class II Terminated

Spicy Shrimp California Roll [WR] UPC: 81244803444 Products were sold from Genji Sushi counters inside Whole Foods Market stores

August 13, 2021 Mai Cuisine 1490 packages - all Genji products units
FDA Drug Class II Terminated

METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Drug Class II Terminated

TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Drug Class II Terminated

DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Drug Class II Terminated

HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Drug Class II Terminated

Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Drug Class II Terminated

TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Food Class II Completed

FLEISCHMANN'S YEAST COMPRESSED FRESH ESL 24/1lbs Paper/Foil overwrap

August 13, 2021 Sysco Atlanta, LLC 31cs/24/1lbs Paper/Foil overwrap units
FDA Drug Class II Terminated

TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Food Class II Terminated

Hotdog buns, customer specified formula, in unlabeled clear plastic bags, 30 or 12 buns per bag.

August 13, 2021 Kansas City LLC., DBA Best Harvest Bakeries 10,712 buns total units
FDA Drug Class II Terminated

GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Food Class II Completed

I SICILIANI PRIMOSALE PEPATO sheep's milk cheese with black pepper 2/5lbs Plastic overwrap PRODUCT OF ITALY

August 13, 2021 Sysco Atlanta, LLC 1cs/2/5lbs Plastic overwrap units
FDA Drug Class II Terminated

SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Food Class II Terminated

12pc Shrimp Tempura Kabuki Roll WR UPC: 8 4003140626 2 Product was sold from Mai Sushi counters inside Target stores in Northern CA.

August 13, 2021 Mai Cuisine 67 packages. units
FDA Drug Class II Terminated

PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Food Class II Completed

KEN'S STEAKHOUSE DRESSING ASIAN SESAME DRESSING 4/1gallon Plastic container Ken's Foods Inc Marlborough, MA 01752 MUST BE REFRIGERATED

August 13, 2021 Sysco Atlanta, LLC 28/4/1gallon Plastic container units
FDA Food Class II Terminated

Double Shrimp BBQ Roll WR UPC: 81244803204 Products were sold from Genji Sushi counters inside Whole Foods Market stores

August 13, 2021 Mai Cuisine 1490 packages - all Genji Products units
FDA Drug Class II Terminated

METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

August 13, 2021 First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy N/A units
FDA Food Class II Terminated

SPECIAL ROLL SUPER SET 16PC UPC: 81282401129 Product was sold from Mai Sushi counters inside New Leaf Community Market stores in Northern CA.

August 13, 2021 Mai Cuisine 103 packages - all products for New Leaf Market stores. units