Product Recalls in 2016

5,616 recalls issued this year

330

CPSC

3,066

FDA Food

1,199

FDA Drug

1,021

NHTSA

FDA Drug Class II Terminated

Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

September 21, 2016 Wells Pharmacy Network, LLC a) 694 vials b) 389 vials c) 695 vials d) 5193 vials units
FDA Drug Class II Terminated

Titan Up (INOS/CHOL/LEU/CAR/CHRO/LID) Injectable 25 mg/25 mg/1.5 mg/25 mg/0.025 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL

September 21, 2016 Wells Pharmacy Network, LLC 433 vials units
FDA Drug Class II Terminated

Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL

September 21, 2016 Wells Pharmacy Network, LLC 1,250 vials units
FDA Food Class I Terminated

BLUE BELL(R) ICE CREAM Blue Monster, 3 Gallons

September 20, 2016 Blue Bell Creameries, L.P. 8909 units units
FDA Food Class I Terminated

BLUE BELL(R) ICE CREAM Cookie Two Step, Half Gallon and Pint sizes

September 20, 2016 Blue Bell Creameries, L.P. 1,531,902 units units
FDA Drug Class II Terminated

Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-01

September 20, 2016 Leiter's Compounding 76,315 total units, all products units
FDA Drug Class II Terminated

Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35

September 20, 2016 Leiter's Compounding 76,315 total units, all products units
FDA Food Class I Terminated

GMO Free Cookie Dough 03-377, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 780 cases units
FDA Food Class I Terminated

Cinnamon Bun Cookie Dough 05-3718 NET WT. 30 lb (13.61 kg), Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 33 cases units
CPSC Ongoing

Denon Recalls Rechargeable Battery Packs Due to Fire and Burn Hazards

September 20, 2016 About 3,400 (in addition, 240 were sold in Canada) units
FDA Food Class I Terminated

Brownie Dough Pieces PVD# 3722

September 20, 2016 Aspen Hills, Inc. 279 cases units
FDA Food Class I Terminated

Snickerdoodle Cookie Dough 1041197 NET WT. 30 lb (13.61 kg), Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 745 cases units
FDA Food Class I Terminated

Peanut Butter Cookie Dough Item 06-371, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 71 cases units
FDA Food Class I Terminated

BLUE BELL(R) ICE CREAM Krazy Kookie Dough, 3 Gallons

September 20, 2016 Blue Bell Creameries, L.P. 3699 units units
NHTSA Ongoing

Incorrect Label on Brake Fluid Container/FMVSS 116

September 20, 2016 PORSCHE CARS NORTH AMERICA, INC. 32,944 units
NHTSA Ongoing

Anti-Rollbar Links may Shift out of Position

September 20, 2016 PORSCHE CARS NORTH AMERICA, INC. 243 units
NHTSA Ongoing

Final Drive Pulley Nut Insufficiently Tightened

September 20, 2016 DUCATI NORTH AMERICA 1,433 units
FDA Food Class I Terminated

Chocolate Chip Cookie Dough Supplier Number: CS03-105 NET WT. 25 lb (11.3 kg), Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 6,055 cases units
NHTSA Ongoing

Pressure Relief Device may Fracture

September 20, 2016 NEW FLYER INDUSTRIES LTD 38 units
FDA Food Class I Terminated

Green Sugar Cookie Dough 05-597, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 120 cases units
FDA Drug Class II Terminated

Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39

September 20, 2016 Leiter's Compounding 76,315 total units, all products units
FDA Food Class I Terminated

GMO Free Brownie Dough 04-377, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 527 cases units
FDA Food Class I Terminated

Cookie Dough Pieces Chocolate Chip 10004490 NET WT. 30 lb (13.61 kg), Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 1,680 cases units
FDA Drug Class II Terminated

Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35

September 20, 2016 Leiter's Compounding 76,315 total units, all products units
FDA Drug Class II Terminated

Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA

September 20, 2016 Leiter's Compounding 76,315 total units, all products units
FDA Food Class I Terminated

Pink Sugar Cookie Dough 05-599, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 120 cases units
FDA Food Class I Terminated

Chocolate Chip Cookie Dough in the following packaging configurations 1) Item 03-3003 NET WT. 30 lb (13.61 kg), Aspen Hills, Inc. Garner, IA 50438; 2) 03-300 NET WT. 10 lb (4.54 kg), Aspen Hills,

September 20, 2016 Aspen Hills, Inc. 1) 70 cases; 2) 2,397 cases; 3) 600 cases units
FDA Drug Class II Terminated

Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35

September 20, 2016 Leiter's Compounding 76,315 total units, all products units
FDA Food Class I Terminated

Brownie Dough 04-371, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 106 cases units
FDA Food Class I Terminated

BLUE BELL(R) ICE CREAM Chocolate Chip Cookie Dough, Half Gallon, Pint, and 3 Gallon sizes.

September 20, 2016 Blue Bell Creameries, L.P. 4,288,629 units units
FDA Drug Class II Terminated

Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 703

September 20, 2016 Leiter's Compounding 76,315 total units, all products units
FDA Food Class I Terminated

Cookie Dough - Chocolate Chip - No Egg 03-307 NET WT. 30 lb (13.61 kg), Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 406 cases units
FDA Food Class I Terminated

Blue Sugar Cookie Dough 05-598, NET WT. 30 lbs (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 120 cases units
FDA Food Class I Terminated

NO EGG CHOCOLATE CHIP COOKIE DOUGH 03-3014, Net Weight 30 lb (13.61 Kg) Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 14,494 cases units
FDA Food Class I Terminated

Cold Stone Creamery RTE Cookie Dough Puck 2505, NET WT. 22.5 lb (10.215 kg), Aspen Hills, Inc.

September 20, 2016 Aspen Hills, Inc. 7,185 cases units
FDA Food Class I Terminated

Cold Stone Creamery RTE Sugar Cookie Dough Puck 2006, NET WT. 22.5 lbs (10.206 Kg)

September 20, 2016 Aspen Hills, Inc. 1,015 cases units
FDA Drug Class II Terminated

Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35

September 20, 2016 Leiter's Compounding 76,315 total units, all products units
FDA Food Class I Terminated

Chocolate Chip Cookie Dough 03-3012 NET WT. 25 lb (11.36 kg), Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 2,361 cases units
FDA Food Class I Terminated

Chocolate Chip Cookie Dough 03-301 NET WT. 30 lb (13.61 kg), Aspen Hills, Inc. Garner, IA 50438

September 20, 2016 Aspen Hills, Inc. 5,102 cases units
FDA Drug Class II Terminated

Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35

September 20, 2016 Leiter's Compounding 76,315 total units, all products units
FDA Drug Class III Terminated

Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

September 19, 2016 Wells Pharmacy Network, LLC 353 pellets units
FDA Drug Class II Terminated

Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network

September 19, 2016 Wells Pharmacy Network, LLC 358 pellets units
NHTSA Ongoing

Intermittent Power Steering Assist Loss

September 19, 2016 Spartan Motors USA 264 units
NHTSA Ongoing

Headlamp Clips may not be Properly Secured

September 19, 2016 MITSUBISHI MOTORS NORTH AMERICA, INC. 587 units
FDA Drug Class III Terminated

Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network

September 19, 2016 Wells Pharmacy Network, LLC 301 pellets units
FDA Drug Class II Terminated

Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network

September 19, 2016 Wells Pharmacy Network, LLC 690 pellets units
FDA Drug Class II Terminated

Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network

September 19, 2016 Wells Pharmacy Network, LLC 318 pellets units
NHTSA Ongoing

Rivet Failure may Cause RAD to Detach

September 19, 2016 UTILITY TRAILER MANUFACTURING COMPANY 66 units
FDA Food Class II Terminated

Kelloggs ¿ Eggo ¿ Nutri-Grain¿ Whole Wheat Waffles 12.3 oz (10 ct) retail carton 8, 12.3 oz retail cartons per case

September 19, 2016 Kellogg Company 10,950 Cases units
FDA Drug Class III Terminated

Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network

September 19, 2016 Wells Pharmacy Network, LLC 1 pellet units