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
Benefiber Fiber Drink Mix, Kiwi Strawberry, Sugar Free, packaged in 5.0-oz. boxes containing 24/0.21-oz. stick packs, UPC 300670106249. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ
May 7, 2013
Novartis Consumer Health
152,016/5.0-oz. (24-ct) boxes units
FDA Food
Class II
Terminated
Benefiber Fiber Supplement Plus Calcium, Orange Natural Flavor, Sugar Free, packaged in 10.76-oz (48 Servings) bottles, UPC 300670108489. Distributed by: Novartis Consumer Health, Inc., Parsippany,
May 7, 2013
Novartis Consumer Health
110,664/10.76-oz (48 Servings) bottles units
FDA Drug
Class III
Terminated
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC
May 7, 2013
Hill Dermaceuticals, Inc.
8,808 bottles units
FDA Food
Class II
Terminated
Benefiber Fiber Supplement, Orange Natural Flavor, Non-Thickening Powder, Sugar Free, packaged in 5.7-oz. (35 servings) bottles, UPC 300670068356, 9.4-oz (58 servings) bottles, UPC 300670068585, and 1
May 7, 2013
Novartis Consumer Health
226,381 consumer units units
FDA Drug
Class I
Terminated
Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).
May 6, 2013
Chang Kwung Products
3,720 capsules total units
NHTSA
Ongoing
Hybrid Charging System/Possible Fire or Stall
May 6, 2013
GENERAL MOTORS LLC
42,904 units
NHTSA
Ongoing
Incorrectly Welded Shock Absorbers
May 6, 2013
KONI NORTH AMERICA
39 units
FDA Drug
Class I
Terminated
Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).
May 6, 2013
Chang Kwung Products
3,720 capsules total units
NHTSA
Ongoing
Unexpected Unfurling of the Awning
May 6, 2013
DUTCHMEN MANUFACTURING, INC.
5 units
FDA Food
Class III
Terminated
Red Bone Alley Restaurant Wasabi All Natural Sauce for all Seafood & Chicken, Net Wt. 12 fl oz. Distributed by: Red Bone Alley Foods, LLC, 1903 W. Palmetto Street, Florence, SC 29501. Clear Plastic
May 6, 2013
National Food & Beverage, Inc
3388 cases units
FDA Food
Class I
Terminated
Hannaford Gourmet Oatmeal Raisin Cookies (9 oz. package) UPC # 0004126872715
May 4, 2013
Delhaize America (Hannaford Bros)
2899- 9 oz cookies units
FDA Food
Class I
Terminated
Hanna ford Gourmet Cookie Platter (36 oz. package), Includes oatmeal raisin cookies UPC # 04126874662
May 4, 2013
Delhaize America (Hannaford Bros)
154 platters (36 oz) units
FDA Food
Class I
Terminated
Pure Herbs, Ltd. Natural Herbal Extracts Protein Dietary Supplement.120mL/4 fl. oz. bottle; 30mL/1 fl.oz bottle.
May 4, 2013
Pure Herbs Ltd
813 x 4oz bottles and 72 x 1oz bottles units
FDA Food
Class II
Terminated
Senora Verde Taco Dinner Kit, 12ct, 9.75 oz (276g), 12 cartons per case.
May 3, 2013
Gruma Corp
132 cases were shipped and retrieved units
NHTSA
Ongoing
Leaking Brake Pressure may Lead to Wheel End Fire
May 3, 2013
PREVOST CARS, INC.
416 units
FDA Food
Class II
Terminated
Master Cases, Product Code #8534 (6-12 count retail boxes) Label of master case bears the name: Donut House K -Cup Packs. 12-Count Retail Boxes, Product Code #8934, Donut House Decaffeinated K-Cup P
May 3, 2013
Green Mountain Coffee Roasters
288,144 kcups/4,002 master cases (6 retail boxes per case)/ 24,012 retail boxes units
FDA Food
Class III
Terminated
Berkshire Blue Cheese, Made from Whole Unpasteurized Cow's' Milk. Aged 60 days Unit size: 2-3 Lb. wheels Wrapped in wax paper then plastic
May 3, 2013
Berkshire Cheese LLC
149 lbs units
FDA Drug
Class II
Terminated
Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2
May 3, 2013
Kareway Product Inc
24,048 cartons units
FDA Food
Class II
Terminated
Talenti Roman Raspberry Sorbetto, 16fl oz, Crafted by Talenti, Marietta, GA 30062
May 3, 2013
Talenti Gelato
420 cases (2260/16 fl oz units) units
FDA Drug
Class II
Terminated
Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
20 vials of 5mL units
FDA Drug
Class II
Terminated
Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
41 vials of 2mL units
NHTSA
Ongoing
Throttle Limp-Mode Software Fault
May 2, 2013
Volvo Bus Corporation
285 units
FDA Drug
Class II
Terminated
MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
10 vials of 30 mL each units
FDA Drug
Class II
Terminated
Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
2 vials of 250mL and 26 vials of 100mL units
FDA Drug
Class II
Terminated
Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 vials of 10mL units
FDA Drug
Class II
Terminated
Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
1 vial of 6mL, 19 vials of 10mL each and 1 vial of 40mL units
FDA Drug
Class II
Terminated
MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
14 vials of 30mL each units
FDA Food
Class II
Terminated
DiGiorno pizzeria, bianca/white pizza , Net Wt.18.0 OZ (510 g), UPC 71921-91484
May 2, 2013
Nestle USA, Inc - Northbrook Pizza Head Office
5,958 cases (10 pizzas/case) units
CPSC
Ongoing
Louisville Slugger OneX Fastpitch Softball Bats Recalled by Hillerich & Bradsby Due to Injury Hazard from Breakage
May 2, 2013
About 13,000 units
CPSC
Ongoing
LEM Products Distribution Recalls 5-Tray Food Dehydrators Due to Fire Hazard
May 2, 2013
About 14,600 in the U.S, and 100 in Canada. This product was previously recalled in February 2011. units
FDA Food
Class II
Terminated
california Pizza Kitchen crispy thin crust, White, Crispy thin crust pizza topped with garlic creme fraiche sauce, spinach, garlic, mozzarella,cheeses, parmesan, asiago and romano cheeses. Net Wt.12.
May 2, 2013
Nestle USA, Inc - Northbrook Pizza Head Office
16,163 cases (14 pizzas/case) units
NHTSA
Ongoing
Passenger Side Air Bag Inflator may Rupture
May 2, 2013
BMW OF NORTH AMERICA, LLC
43,204 units
FDA Drug
Class II
Terminated
Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.
May 2, 2013
Hospira, Inc.
168,300 vals units
FDA Drug
Class II
Terminated
Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
7 vials of 50mL each units
FDA Drug
Class II
Terminated
Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
3 vials of 45mL units
FDA Drug
Class II
Terminated
Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
4 vials of 10mL each units
FDA Drug
Class II
Terminated
Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
80 vials of 4mL each units
FDA Drug
Class II
Terminated
Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
32 vials of 50mL units
FDA Drug
Class II
Terminated
Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
78 vials of 500ml and 92 vials of 100mL units
FDA Drug
Class II
Terminated
B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
56 vials of 50mL units
FDA Drug
Class II
Terminated
Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
43 vials of 250mL each units
FDA Drug
Class II
Terminated
Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
1 vial of 40mL units
FDA Drug
Class II
Terminated
Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
2 vials of 100mL units
FDA Drug
Class II
Terminated
Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
1 vial of 22mL units
FDA Drug
Class II
Terminated
Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
44 vials of 50mL each units
FDA Food
Class I
Terminated
Jumbo Barcelona in-shell hazelnuts and Large Barcelona in-shell hazelnuts, raw, Hazelnut Growers of Oregon Brand, package in bulk 50 pound screen-printed fabric sack. The product is labeled in p
May 2, 2013
Hazelnut Growers of Oregon
5000 lbs. Jumbo Barcelona and 5000 lbs. Large Barcelona in-shell hazelnuts units
FDA Drug
Class II
Terminated
Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
4 vials of 5mL and 22 vials of 10mL units
FDA Drug
Class II
Terminated
Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
1 vial of 20mL and 1 vial of 40mL units
FDA Drug
Class II
Terminated
Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
5 vials of 50mL units
FDA Drug
Class II
Terminated
Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
May 2, 2013
THE COMPOUNDING SHOP, INC.
55 vials of 100mL units