Product Recalls in 2018

4,897 recalls issued this year

258

CPSC

1,977

FDA Food

1,681

FDA Drug

981

NHTSA

FDA Drug Class III Terminated

Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material

August 14, 2018 United Therapeutics Corp. 2801 devices units
CPSC Ongoing

Koehler-Bright Star Recalls Flashlights Due to Explosion Hazard

August 14, 2018 Koehler-Bright Star, of Hanover, Pa. About 7,500 (In addition, 200 were sold in Canada) units
FDA Drug Class III Terminated

Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC

August 14, 2018 Jubilant Cadista Pharmaceuticals Inc. 7,048 bottles units
FDA Drug Class II Terminated

Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

August 14, 2018 AVKARE Inc. 728 cartons (36,400 tablets) units
FDA Drug Class II Terminated

Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478

August 14, 2018 AVKARE Inc. 6776 cartons (338,800 tablets) units
FDA Drug Class III Terminated

Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC

August 14, 2018 Jubilant Cadista Pharmaceuticals Inc. 18,947 bottles units
FDA Drug Class III Terminated

Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC

August 14, 2018 Jubilant Cadista Pharmaceuticals Inc. 9,552 bottles units
NHTSA Ongoing

Voltage Regulator may Fail and Cause Stall

August 14, 2018 Chrysler (FCA US LLC) 12,779 units
FDA Drug Class II Terminated

Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

August 14, 2018 AVKARE Inc. 818 cartons (40,900 tablets) units
FDA Drug Class III Terminated

Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08

August 14, 2018 Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 408 cartons units
FDA Drug Class II Terminated

Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 Dist. By: McKesson Packaging

August 14, 2018 Mckesson Corporation 1531 cartons units
FDA Drug Class II Terminated

Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

August 14, 2018 AVKARE Inc. 1496 cartons (44,880 tablets) units
FDA Food Class I Terminated

Chocolate Gooey Brownie Ice Cream, packaged in pint-sized containers (473 mL), net wt 378 g; 1 gal. container, or 3 gal. tubs. 3 gal. tubs were sold to Salt & Straw Retail Scoop Shops only. 1 ga

August 14, 2018 SALT & STRAW LLC 4,088 Pints; 661/3 Gallon Tubs; 18/1 Gallon Tubs units
FDA Food Class II Terminated

Bok Choy was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 30 lbs. (5 lb. boxes) units
FDA Food Class II Terminated

Collards were shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 2 dozens units
FDA Food Class II Terminated

Cilantro was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 5 dozens, 30 ct, 6 boxes units
FDA Food Class II Terminated

Kale was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 2 dozens units
FDA Food Class II Terminated

Lacinato Kale was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 2 dozen units
FDA Food Class II Terminated

Green Chard was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 1 dozen units
FDA Food Class II Terminated

Red Chard was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 1 dozen units
NHTSA Ongoing

Undersized Weld at Auger Coupler

August 13, 2018 Terex South Dakota, Inc. 101 units
FDA Food Class II Terminated

Spinach was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 2 dozens units
NHTSA Ongoing

Insufficient Coating on Rear Brake Caliper Pistons

August 13, 2018 Chrysler (FCA US LLC) 154,335 units
FDA Food Class II Terminated

Napa Cabbage was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 30 lbs.; 15 lbs. and 2 lbs. boxes units
FDA Food Class II Terminated

Dill was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 6 ct units
FDA Food Class II Terminated

Italian Parsley was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 5 dozen units
NHTSA Ongoing

Brake Support Bolt may Break

August 13, 2018 BYD Coach & Bus 14 units
FDA Food Class II Terminated

Beet was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 1 dozen units
FDA Food Class II Terminated

Mustard was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 2 dozens units
NHTSA Ongoing

Improperly Wired Warning Lights on Portable Pumps

August 13, 2018 Hale Products Inc 356 units
FDA Food Class II Terminated

Green Leaf Lettuce was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 2 dozens units
FDA Drug Class I Terminated

Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Living Well Remedies, LLC P.O. Box 704, Franklin Lakes, NJ 07417 www.LivingWellRemedies.com. Made in the USA

August 13, 2018 Living Well Remedies, LLC 128 (2 fl oz spray bottles) units
NHTSA Ongoing

Pitman Arms May Fracture

August 13, 2018 Daimler Trucks North America LLC 116 units
NHTSA Ongoing

Incorrect Location of Emergency Exit/FMVSS 217

August 13, 2018 Garden State Bus Group 20 units
FDA Drug Class II Terminated

Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03

August 13, 2018 Lupin Pharmaceuticals Inc. 11,706 bottles units
FDA Food Class II Terminated

Romaine Lettuce was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 2 dozens units
FDA Food Class II Terminated

Bright Light Chard was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 1 dozen units
FDA Food Class II Terminated

Parsley was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 5 dozens (30 ct. 6 ct) units
FDA Food Class II Terminated

Red Leaf Lettuce was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 2 dozens units
FDA Food Class II Terminated

Mint was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002".

August 13, 2018 Howard Calcagno Farms 5 dozen units
FDA Drug Class II Terminated

Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19

August 10, 2018 RemedyRepack Inc. 36 bottles of 90 = 3240 tablets units
NHTSA Ongoing

Entry Door may Open Unexpectedly

August 10, 2018 NEWMAR CORPORATION 239 units
FDA Drug Class II Terminated

Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19

August 10, 2018 RemedyRepack Inc. 21 bottles of 90 = 1890 tablets units
NHTSA Ongoing

Incorrectly Installed Seat Belt Anchorage Plate

August 10, 2018 CORP. MICRO BIRD, INC. 155 units
NHTSA Ongoing

Incorrectly Installed Seat Belt Anchorage Plate

August 10, 2018 CORP. MICRO BIRD, INC. 136 units
NHTSA Ongoing

Centerstand Circlip May Break

August 10, 2018 HONDA (AMERICAN HONDA MOTOR CO.) 2,933 units
FDA Drug Class II Terminated

ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- ND

August 10, 2018 Westlab Pharmacy, Inc. dba Westlab Pharmacy 222 syringes units
FDA Drug Class II Terminated

Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00

August 10, 2018 Westlab Pharmacy, Inc. dba Westlab Pharmacy 80 syringes units
FDA Drug Class II Terminated

Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19

August 10, 2018 RemedyRepack Inc. 9 bottles of 90 = 810 tablets units
FDA Drug Class II Terminated

Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92

August 10, 2018 Westlab Pharmacy, Inc. dba Westlab Pharmacy 7 droptainers units