Product Recalls in 2017
4,951 recalls issued this year
280
CPSC
2,623
FDA Food
1,141
FDA Drug
907
NHTSA
FDA Drug
Class II
Terminated
FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR KR, FOR MANUFACTURING, PROCESSING OR REPACKAGING
September 27, 2017
Pfizer Manufacturing Deutschland GmbH
a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets units
NHTSA
Ongoing
Reflex Reflectors may not be Visible/FMVSS 108
September 26, 2017
BMW OF NORTH AMERICA, LLC
1,478 units
FDA Drug
Class III
Terminated
HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-16
September 26, 2017
Pharmedium Services, LLC
Unknown units
NHTSA
Ongoing
LP Line Damage may Result in Fire
September 26, 2017
JAYCO, INC.
374 units
NHTSA
Ongoing
Driveshaft Catch Strap Not Installed
September 26, 2017
Daimler Vans USA, LLC
109 units
NHTSA
Ongoing
Loss of Electronic Power Steering Assist
September 26, 2017
Daimler Vans USA, LLC
3 units
NHTSA
Ongoing
Tie Rod may Loosen
September 26, 2017
PACCAR, INCORPORATED
17,737 units
FDA Drug
Class II
Terminated
Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20
September 26, 2017
Pharmedium Services, LLC
2390 syringes units
CPSC
Ongoing
Saber Grills Recalls Grills and LP Regulators Due to Fire and Burn Hazards
September 26, 2017
About 18,800 grills and 2,900 warranty parts and conversion kits (in addition, 7,700 grills and 500 warranty parts and conversion kits were sold in Canada) units
FDA Drug
Class II
Terminated
Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, In
September 26, 2017
The Harvard Drug Group
3,935 cartons units
FDA Drug
Class III
Terminated
morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78
September 26, 2017
Pharmedium Services, LLC
Unknown units
NHTSA
Ongoing
Inconsistent Adhesive On Panel Joints/FMVSS 221
September 26, 2017
FOREST RIVER, INC.
10 units
NHTSA
Ongoing
Tie Rod may Loosen
September 26, 2017
FORD MOTOR COMPANY
77 units
FDA Drug
Class III
Terminated
morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC
September 26, 2017
Pharmedium Services, LLC
Unknown units
FDA Drug
Class II
Terminated
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
September 25, 2017
RXQ Compounding LLC
945 vials units
FDA Drug
Class III
Terminated
Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceutic
September 25, 2017
Amneal Pharmaceuticals, Inc.
19176 units units
FDA Drug
Class III
Terminated
Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceut
September 25, 2017
Amneal Pharmaceuticals, Inc.
19104 units units
FDA Drug
Class III
Terminated
Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc.
September 25, 2017
Sandoz, Inc
13,435 shrink wrap packs units
NHTSA
Ongoing
Seats are Missing Reinforcement Bracket
September 25, 2017
Daimler Trucks North America LLC
53 units
CPSC
Ongoing
Pro-Tec Recalls Multisport Helmets Due to Risk of Head Injury
September 25, 2017
Pro-Tec, a division of Bravo Sports, of Santa Fe Springs, Calif.
About 4,600 units
CPSC
Ongoing
Delta Recalls Strollers Due to Fall Hazard
September 25, 2017
About 28,000 units
NHTSA
Ongoing
Seats are Missing Reinforcement Bracket
September 25, 2017
Daimler Trucks North America LLC
28 units
NHTSA
Ongoing
Seat Mounting Washers may Crack and Dislodge
September 25, 2017
FOREST RIVER, INC.
707 units
NHTSA
Ongoing
Battery Cable may Chafe and Short on Axle Yoke
September 25, 2017
Daimler Trucks North America LLC
32 units
FDA Drug
Class III
Terminated
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (ND
September 25, 2017
Precision Dose Inc.
801 cases units
NHTSA
Ongoing
Improperly Heat Treated Crankshaft May Cause Stall
September 25, 2017
Kia Motors America
62 units
FDA Food
Class I
Terminated
Instant Reishi Coffee, 4 in 1; Ca Phe Ling Chi; 20 sachets, Net Wt. 360g (12.7 oz.) UPC 8 93663 00225 8 Ingredients: Sugar, Non Dairy Creamer, Instant Coffee, Reishi Extract. Chun Yuen Trading,
September 25, 2017
Chun Yuen Trading Co., Inc.
15,947 bags units
NHTSA
Ongoing
Brake Hose may Contact Tire and Leak
September 22, 2017
NAVISTAR, INC
228 units
NHTSA
Ongoing
Tie Rod may Loosen
September 22, 2017
NAVISTAR, INC
160 units
NHTSA
Ongoing
Seat Belt Stuck in Locked Position/FMVSS 209
September 22, 2017
DOUBLE K INC.
16 units
FDA Food
Class I
Terminated
Chicken Salad Sandwich 6.8 oz plastic container Contains: Wheat, Egg, Soy USPC 6 63209-02050 9
September 22, 2017
The Kroger Co
2,634 sandwiches units
FDA Drug
Class III
Terminated
Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, ND
September 22, 2017
Boehringer Ingelheim Pharmaceuticals, Inc.
128 bottles units
NHTSA
Ongoing
Fuel Pump Failure
September 22, 2017
Rosenbauer Motors
1 units
FDA Food
Class I
Terminated
waterfront Bistro Tatar Sauce, Net Wt 9 oz. (255g), UPC 21130-12242
September 22, 2017
Silver Spring Foods, Inc.
11092 cases (6 bottles per case) units
NHTSA
Ongoing
Fuel Filter Flange May Crack Causing Fuel Leak
September 22, 2017
Volkswagen Group of America, Inc.
73,941 units
NHTSA
Ongoing
Battery Tray Separation Leaking Battery Acid
September 22, 2017
REV Recreation Group
934 units
FDA Drug
Class II
Terminated
Medline Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
September 21, 2017
Medline Industries Inc
73 cases units
FDA Drug
Class II
Terminated
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
September 21, 2017
Medline Industries Inc
3800 cases units
FDA Drug
Class II
Terminated
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
September 21, 2017
Medline Industries Inc
98,901 cases units
FDA Drug
Class II
Terminated
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
September 21, 2017
Medline Industries Inc
700 cases units
FDA Drug
Class II
Terminated
Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
September 21, 2017
Medline Industries Inc
100 cases units
FDA Drug
Class II
Terminated
Medline Staple Remover Kit, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
September 21, 2017
Medline Industries Inc
600 cases units
FDA Drug
Class II
Terminated
Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
September 21, 2017
Medline Industries Inc
80 cases units
FDA Drug
Class II
Terminated
Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
September 21, 2017
Medline Industries Inc
375 cases units
FDA Drug
Class II
Terminated
Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1
September 21, 2017
Medline Industries Inc
11,750 cases units
FDA Drug
Class II
Terminated
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
September 21, 2017
Medline Industries Inc
49,587 cases units
FDA Food
Class III
Terminated
New York Deli tempeh sandwich, plum bistro 2go brand, packaged in a transparent plastic clamshell container, sold at 10 oz. or 12 oz. UPC 8 64801 00010 8. The label is read in parts: "***NEW YORK D
September 21, 2017
Quickie Stores, Inc.
50 packages units
FDA Drug
Class II
Terminated
Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
September 21, 2017
Medline Industries Inc
80 cases units
FDA Drug
Class II
Terminated
Medline DC Line Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
September 21, 2017
Medline Industries Inc
363 cases units
FDA Drug
Class II
Terminated
Medline I&D Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
September 21, 2017
Medline Industries Inc
40 cases units