Product Recalls in 2013

5,503 recalls issued this year

290

CPSC

2,420

FDA Food

2,085

FDA Drug

708

NHTSA

FDA Food Class II Terminated

Empirical Labs Building Health Thyroid; 90 Capsules Dietary Supplement

October 21, 2013 Empirical Laboratories, Incorporated 22 units
FDA Food Class II Terminated

Empirical Labs Building Health Superfuel; 240 Capsules Dietary Supplement

October 21, 2013 Empirical Laboratories, Incorporated 61 units
FDA Food Class II Terminated

Empirical Labs Building Health Inte-Zyme; 180 Capsules Dietary Supplement

October 21, 2013 Empirical Laboratories, Incorporated 48 units
FDA Food Class II Terminated

LGS-Zyme (Z12), Enzyme-Based Multivitamin & Amino Acid Dietary Supplement, 120 Capsules

October 21, 2013 Apex Energetics 292 units units
NHTSA Ongoing

Battery Equalizers/DC-DC Converters-Possible Fire

October 21, 2013 NORTH AMERICAN BUS INDUSTRIES, INC. 4,061 units
FDA Food Class II Terminated

Non-GMO Ingredients Go Green Fuel for the Entire Body Dietary Supplement. All-Natural Greens Dietary Supplement. Manufactured Exclusiveley for: Hsin Ten Enterprise USA, Inc. Industry, CA 91748.

October 21, 2013 Empirical Laboratories, Incorporated 5157 units
NHTSA Ongoing

Sunroof may Shatter

October 21, 2013 VOLKSWAGEN OF AMERICA, INC 1,120 units
FDA Food Class II Terminated

Vive Shake Up Your Health Chocolate; Made for and distributed by renewal wellness.

October 21, 2013 Empirical Laboratories, Incorporated 519 units
FDA Food Class II Terminated

Empirical Labs Building Health Vascuzyme; 90 Capsules Dietary Supplement

October 21, 2013 Empirical Laboratories, Incorporated 163 units
NHTSA Ongoing

Rear Trailer Suspension Missing Weld

October 21, 2013 NOV Rolligon 31 units
NHTSA Ongoing

Front Sway Bar may Detach/Loss of Brakes

October 21, 2013 SPARTAN MOTORS, INC. 75 units
FDA Food Class II Terminated

Empirical Labs Building Health SuperFuel Tropical Dietary Supplement

October 21, 2013 Empirical Laboratories, Incorporated 62 units
NHTSA Ongoing

PTO Pressure Switch Oil Leak may Result in Fire

October 21, 2013 ALTEC INDUSTRIES INC. 1,145 units
NHTSA Ongoing

Loss of Brake Assist/Vacuum Pump Lubrication

October 21, 2013 BMW OF NORTH AMERICA, LLC 76,191 units
FDA Food Class II Terminated

Empirical Labs Building Health SuperFuel Plus Mocha Flavor; Whey protein isolate (milk); Dietary Supplement

October 21, 2013 Empirical Laboratories, Incorporated 62 units
NHTSA Ongoing

Soft Front Brake/Increased Stopping Distance

October 21, 2013 Suzuki Motor of America, Inc. 208,966 units
FDA Drug Class II Terminated

LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 65 mL units
FDA Drug Class II Terminated

METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 20 mL units
FDA Drug Class II Terminated

Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 19200 mL units
FDA Drug Class II Terminated

HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 70 mL units
FDA Drug Class II Terminated

Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 11 mL units
FDA Drug Class II Terminated

Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 1351 mL units
FDA Drug Class II Terminated

NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 100 mL units
FDA Drug Class II Terminated

TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 17.5 ml units
FDA Drug Class II Terminated

Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 126 mL units
FDA Drug Class II Terminated

TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 33 mL units
FDA Drug Class II Terminated

EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 30 mL units
FDA Drug Class II Terminated

Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 38 doses units
FDA Drug Class II Terminated

VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 50 mL units
FDA Drug Class II Terminated

Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 2801 doses units
FDA Drug Class II Terminated

Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 5582.6 mL units
FDA Drug Class II Terminated

Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 148.075 ml units
FDA Drug Class II Terminated

METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTAB

October 19, 2013 Specialty Medicine Compounding Pharmacy 726.45 mL units
FDA Drug Class II Terminated

Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate usp, chromium chloride hexahydrate), Rx only, Specialty Medici

October 19, 2013 Specialty Medicine Compounding Pharmacy 186 mL units
FDA Drug Class II Terminated

Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 8090.8 mL units
FDA Drug Class II Terminated

Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 10 mL units
FDA Drug Class II Terminated

WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy a) 1900 injectable; b) 1900 mL topical units
FDA Drug Class II Terminated

TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 5.5 mL units
FDA Drug Class II Terminated

Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 160 grams units
FDA Drug Class II Terminated

DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 70 mL units
FDA Drug Class II Terminated

Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 6 mL units
FDA Drug Class II Terminated

EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 157.08 mL units
FDA Drug Class II Terminated

NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 120 mL units
FDA Drug Class II Terminated

POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 600 mL units
FDA Drug Class II Terminated

CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 5 mL units
FDA Drug Class II Terminated

Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 35.5 mL units
FDA Drug Class II Terminated

HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 420 mL units
FDA Drug Class II Terminated

GLYCERIN-CHROMATED (W/V)* 72% INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 210 mL units
FDA Drug Class II Terminated

FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 4.4 mL units
FDA Drug Class II Terminated

Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidocaine jelly 2%), Rx only, Specialty Medicine Compounding Pharmac

October 19, 2013 Specialty Medicine Compounding Pharmacy 38 doses units