Product Recalls in 2019
4,851 recalls issued this year
241
CPSC
1,807
FDA Food
1,788
FDA Drug
1,015
NHTSA
FDA Drug
Class II
Terminated
C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
July 24, 2019
Colonia Care Pharmacy
1 vial units
FDA Drug
Class II
Terminated
C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
July 24, 2019
Colonia Care Pharmacy
1 droptainer vial units
FDA Drug
Class II
Terminated
C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
July 24, 2019
Colonia Care Pharmacy
1 vial units
FDA Drug
Class II
Terminated
C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
July 24, 2019
Colonia Care Pharmacy
2 vials units
FDA Drug
Class II
Terminated
C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
July 24, 2019
Colonia Care Pharmacy
1 vial units
FDA Drug
Class II
Terminated
C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
July 24, 2019
Colonia Care Pharmacy
1 vial units
FDA Drug
Class II
Terminated
C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
July 24, 2019
Colonia Care Pharmacy
60 nebulizer vials units
FDA Drug
Class II
Terminated
C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
July 24, 2019
Colonia Care Pharmacy
1 vial units
FDA Drug
Class II
Terminated
C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
July 24, 2019
Colonia Care Pharmacy
1 vial units
FDA Drug
Class II
Terminated
C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
July 24, 2019
Colonia Care Pharmacy
6 vials units
NHTSA
Ongoing
Helmet may not Protect from Impact/FMVSS 218
July 24, 2019
Darsan Trading Co.
450 units
NHTSA
Ongoing
Electric Solenoid May Short Circuit and Cause Fire
July 24, 2019
BRAUN CORPORATION
256 units
FDA Food
Class II
Terminated
Winco Foods, Taco Seasoning Mild, Net Wt. 1.25 OZ, Distributed by Winco Foods, LLC, Boise, ID, UPC 0 70552 90126 1
July 24, 2019
CH Guenther & Sons, Inc
646/24/1.25 OZ/packets/cases units
NHTSA
Ongoing
Loss of Stability Control, Brake Assist/FMVSS 126
July 24, 2019
Toyota Motor Engineering & Manufacturing
6,925 units
FDA Food
Class II
Terminated
Great Value Mild Taco Seasoning, Net Wt. 1 OZ, Distributed by Wal-Mart Stores, Inc. Bentonville, AR. UPC 0 78742 24572v0
July 24, 2019
CH Guenther & Sons, Inc
6,770/12/1 OZ/packets/cases units
FDA Food
Class II
Terminated
HEB Taco Seasoning Mix 25% Less Sodium Net Wt. 1.25 OZ, H-E-B San Antonio TX UPC 0 41220 79609 0
July 24, 2019
CH Guenther & Sons, Inc
1,261/24/1.25 OZ/packets/cases units
FDA Food
Class II
Terminated
SIGA Fresh Basil, 1 lb bag, 10 plastic bags (1 lb bag) per carton
July 24, 2019
SIGA LOGISTICS S DE RL DE CV
15,000 1lb bag units
FDA Drug
Class II
Terminated
C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
July 24, 2019
Colonia Care Pharmacy
1 vial units
NHTSA
Ongoing
Passenger Air Bag May Switch Off/FMVSS 208
July 24, 2019
Volkswagen Group of America, Inc.
145,337 units
FDA Drug
Class II
Terminated
C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
July 24, 2019
Colonia Care Pharmacy
12 droptainer bottles units
FDA Drug
Class II
Terminated
C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
July 24, 2019
Colonia Care Pharmacy
1 vial units
FDA Food
Class I
Terminated
Williams Ingredients, Hot BBQ Snack Seasoning, Net Wt. 50 lb, Williams Foods, Inc. Lenexa, KS
July 24, 2019
CH Guenther & Sons, Inc
76 cases units
CPSC
Ongoing
The Boppy Company Recalls Infant Head and Neck Support Accessories Due to Suffocation Hazard
July 23, 2019
14000 units
FDA Drug
Class II
Terminated
Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanp
July 23, 2019
Glenmark Pharmaceuticals Inc., USA
N/A units
NHTSA
Ongoing
Incorrect Bolt Lengths in Wedge Kits
July 22, 2019
MORryde International, Inc.
175 units
FDA Drug
Class II
Terminated
Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.
July 22, 2019
Wise Pharmacy
1 bottle units
FDA Drug
Class II
Terminated
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
July 22, 2019
Wise Pharmacy
97 vials units
FDA Drug
Class II
Terminated
Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
July 22, 2019
Wise Pharmacy
4 vials units
FDA Drug
Class II
Terminated
Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
July 22, 2019
Wise Pharmacy
84 vials units
FDA Drug
Class II
Terminated
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
July 22, 2019
Wise Pharmacy
44 vials units
FDA Drug
Class II
Terminated
Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
July 22, 2019
Wise Pharmacy
1 container units
NHTSA
Ongoing
Incorrect Bolt Lengths for Rotating Pin Box
July 22, 2019
MORryde International, Inc.
2,766 units
FDA Drug
Class II
Terminated
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
July 22, 2019
Wise Pharmacy
32 vials units
NHTSA
Ongoing
Collision-Avoidance Assist may not Engage
July 22, 2019
Kia Motors America
11,423 units
FDA Drug
Class II
Terminated
Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
July 22, 2019
Wise Pharmacy
27 vials units
FDA Drug
Class II
Terminated
Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
July 22, 2019
Wise Pharmacy
1 container units
FDA Drug
Class II
Terminated
Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
July 22, 2019
Wise Pharmacy
14 vials units
FDA Drug
Class II
Terminated
Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
July 22, 2019
Wise Pharmacy
8 vials units
NHTSA
Ongoing
Active Brake Assist May Not Engage
July 22, 2019
MERCEDES-BENZ USA, LLC.
1,957 units
FDA Drug
Class II
Terminated
Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pitham
July 19, 2019
Lupin Pharmaceuticals Inc.
11,832 bottles units
NHTSA
Ongoing
Oil May Leak Onto Exhaust Manifold
July 19, 2019
HYUNDAI MOTOR AMERICA
8,059 units
FDA Food
Class I
Terminated
The Cookie Dough Cafe - Chocolate chip chilled gourmet edible cookie dough; 1.6 oz bars, packaged in plastic wrappers, 16 bars per wholesale case. UPC: 850947006418
July 19, 2019
The Cookie Dough Cafe
16,080 bars units
FDA Food
Class II
Terminated
Fresket Thai Lobster Salad packaged in 5lb plastic container, 2 containers per case, refrigerated
July 19, 2019
Elevation Foods
208 cases (2-5lb containers per case) units
FDA Food
Class II
Terminated
Fresket egg salad packaged in 32oz plastic cup with lid, 2 cups per case, refrigerated
July 19, 2019
Elevation Foods
294 cases (2-32 oz cups per case) units
FDA Drug
Class II
Terminated
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: As
July 19, 2019
Ascend Laboratories LLC
a) 5,472 bottles and b) 5,880 bottles units
FDA Drug
Class II
Terminated
MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
July 19, 2019
Dercher Enterprises, Inc., DBA Gordon Laboratories
277 boxes units
FDA Food
Class I
Terminated
Archer Farms egg salad packaged in 12oz plastic cup with lid, 6 cups per case, refrigerated
July 19, 2019
Elevation Foods
572 cases (6-12oz cups per case) units
FDA Food
Class II
Terminated
Fresket Tuna Salad packaged in 5lb plastic container, 2 containers per case, refrigerated
July 19, 2019
Elevation Foods
13 cases (2- 5lb containers per case) units
NHTSA
Ongoing
Loss of Hydraulic Steering Assist
July 18, 2019
Reyco Granning
426 units
FDA Drug
Class III
Terminated
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
July 18, 2019
Amneal Pharmaceuticals, Inc.
a) 2,256 bottles; b) 240 bottles units