FoodMar 13, 2019
Friendly Fruit Market dba Sid Wainer & Son JANSAL VALLEY DUKKAH NET WT 2.5 oz recall — FDA F-1138-2019
Customer found piece of glass in the product.
Class IIFDA: TerminatedFriendly Fruit Market dba Sid Wainer & Son
March 2019 recalls — page 8
These records include useful source details for the selected month.
FoodMar 13, 2019
Southern Specialties Marketside BUTTERNUT SQUASH CUBES 16 OZ recall — FDA F-1225-2019
A food contact surface at the firm's supplier facility tested positive for Listeria monocytogenes. Product packed on this table was shipped to Southern Specialties.
Class IIFDA: TerminatedSouthern Specialties, Inc.
FoodMar 13, 2019
Kingston Pharma DG Baby Gripe Water herbal supplement with organic ginger and recall — FDA F-1171-2019
Presence of an undissolved ingredient, citrus flavonoid.
Class IFDA: TerminatedKingston Pharma LLC
DrugMar 13, 2019
Apotex Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 recall — FDA D-0992-2019
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Class IIFDA: CompletedApotex Inc.
DrugMar 13, 2019
Todd Holiday dba Sunstone Organics Maeng Da Kratom recall — FDA D-0986-2019
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class IFDA: TerminatedTodd Holiday dba Sunstone Organics
DrugMar 13, 2019
Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles recall — FDA D-1066-2019
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Class IIFDA: TerminatedAscend Laboratories LLC
DrugMar 13, 2019
Todd Holiday dba Sunstone Organics Maeng Da Kratom recall — FDA D-0989-2019
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class IFDA: TerminatedTodd Holiday dba Sunstone Organics
DrugMar 13, 2019
Petra Hygienic Systems Int ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 recall — FDA D-0994-2019
Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
Class IIIFDA: TerminatedPetra Hygienic Systems Int Ltd
DrugMar 13, 2019
Todd Holiday dba Sunstone Organics White Vein Kratom recall — FDA D-0987-2019
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class IFDA: TerminatedTodd Holiday dba Sunstone Organics
DrugMar 13, 2019
Leiter's Enterprises Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in recall — FDA D-0518-2019
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Class IIFDA: TerminatedLeiter's Enterprises, Inc.
DrugMar 13, 2019
Todd Holiday dba Sunstone Organics White Vein Kratom recall — FDA D-0988-2019
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
Class IFDA: TerminatedTodd Holiday dba Sunstone Organics
DrugMar 13, 2019
Vi-Jon Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent 32 recall — FDA D-0520-2019
Cross Contamination: Presence of IPA in finished product.
Class IIFDA: TerminatedVi-Jon, Inc.
DrugMar 13, 2019
Jubilant Cadista Pharmaceuticals BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) recall — FDA D-0519-2019
Failed Dissolution Specifications; 9-monthstability timepoint
Class IIIFDA: TerminatedJubilant Cadista Pharmaceuticals, Inc.
VehicleMar 7, 2019
General Motors seats recall — NHTSA campaign 19V184000
General Motors LLC (GM) is recalling certain Chevrolet Equinox and GMC Terrain vehicles. The rear-right seat may have insufficient welds on the head-restraint bracket.
seatsGeneral Motors LLC
Medical DeviceMar 6, 2019
Arrow International AF 550 x 5ML/HR CPNB, Product code MC0050XL CPNB, Arrow AutoFuser recall — FDA Z-0949-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Arrow International AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP recall — FDA Z-0947-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Arrow International AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB recall — FDA Z-0941-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Zimmer Biomet Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766 recall — FDA Z-0938-2019
Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMar 6, 2019
Merge Healthcare The WinStation Retinal Imager, also known as Merge Eye Station recall — FDA Z-0939-2019
Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable…
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceMar 6, 2019
Becton Dickinson & Co Phoenix AST-s Indicator, Catalog Number 246009 recall — FDA Z-0933-2019
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceMar 6, 2019
Organon Teknika Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID recall — FDA Z-0962-2019
This notice has been initiated due to potential for compromised test card Top Seal Integrity which could: - yield false resistance for antibiotics on the AST panel - cause a false negative…
Class IIFDA: TerminatedOrganon Teknika Inc.
Medical DeviceMar 6, 2019
Arrow International AF550x5ML/H 2ML 60LO 6" CATH, 4.5" IN, Product code MT5060XLSK5 CP recall — FDA Z-0942-2019
Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMar 6, 2019
Becton Dickinson & Co Phoenix AP AST Indicator Bag, Catalog Number 246006 recall — FDA Z-0935-2019
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceMar 6, 2019
ICU Medical icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System recall — FDA Z-0805-2019
There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
Class IFDA: TerminatedICU Medical, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.