FoodNov 28, 2018
BAZZINI S ROASTED & SALTED IN-SHELL SUPER COLOSSAL PISTACHIOS recall — FDA F-0651-2019
The product tested positive for Salmonella.
Class IFDA: TerminatedBazzini LLC
November 2018 recalls — page 3
These records include useful source details for the selected month.
DrugNov 28, 2018
AMERICAN HEALTH PACKAGING Nitrofurantoin Capsules USP recall — FDA D-0273-2019
Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by…
Class IIIFDA: TerminatedAMERICAN HEALTH PACKAGING
DrugNov 28, 2018
Sciegen Pharmaceuticals Westminister Irbesartan Tablets, USP, 300mg recall — FDA D-0269-2019
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class IIFDA: TerminatedSciegen Pharmaceuticals Inc.
DrugNov 28, 2018
Ecolab Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz) recall — FDA D-0275-2019
Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
Class IIFDA: TerminatedEcolab Inc.
DrugNov 28, 2018
Golden State Medical Supply IRBESARTAN Tablets, USP 75 mg 90-count bottle recall — FDA D-0263-2019
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Class IIFDA: TerminatedGolden State Medical Supply Inc.
DrugNov 28, 2018
Golden State Medical Supply IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle recall — FDA D-0264-2019
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Class IIFDA: TerminatedGolden State Medical Supply Inc.
DrugNov 28, 2018
Sciegen Pharmaceuticals GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle recall — FDA D-0272-2019
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class IIFDA: TerminatedSciegen Pharmaceuticals Inc.
DrugNov 28, 2018
L. Perrigo Company Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count recall — FDA D-0266-2019
Presence of foreign substance: Product found to contain metal particles.
Class IIFDA: TerminatedL. Perrigo Company
DrugNov 28, 2018
Sciegen Pharmaceuticals GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle recall — FDA D-0270-2019
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class IIFDA: TerminatedSciegen Pharmaceuticals Inc.
DrugNov 28, 2018
Sciegen Pharmaceuticals Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle recall — FDA D-0268-2019
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class IIFDA: TerminatedSciegen Pharmaceuticals Inc.
DrugNov 28, 2018
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack recall — FDA D-0283-2019
Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugNov 28, 2018
Sciegen Pharmaceuticals GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle recall — FDA D-0271-2019
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class IIFDA: TerminatedSciegen Pharmaceuticals Inc.
DrugNov 28, 2018
Golden State Medical Supply IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle recall — FDA D-0265-2019
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Class IIFDA: TerminatedGolden State Medical Supply Inc.
DrugNov 28, 2018
Sciegen Pharmaceuticals Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle recall — FDA D-0267-2019
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class IIFDA: TerminatedSciegen Pharmaceuticals Inc.
DrugNov 28, 2018
ECOLAB Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz recall — FDA D-0274-2019
Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
Class IIFDA: TerminatedEcolab Inc.
VehicleNov 28, 2018
Honda roof and pillars recall — NHTSA campaign 18V848000
Honda (American Honda Motor Co.) is recalling certain 2019 Honda Ridgeline and Pilot vehicles. The mounting holes for the clip that secures the right center pillar trim panel may be larger…
roof and pillarsHonda (American Honda Motor Co.)
VehicleNov 26, 2018
Volkswagen Group of instrument cluster/panel recall — NHTSA campaign 18V824000
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2018-2019 Volkswagen Atlas and Tiguan and 2019 Volkswagen Jetta vehicles that do not have keyless entry. The instrument…
instrument cluster/panelVolkswagen Group of America, Inc.
Medical DeviceNov 21, 2018
AROA Biosurgery OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G recall — FDA Z-0426-2019
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Class IIFDA: TerminatedAROA Biosurgery, LTD.
Medical DeviceNov 21, 2018
Straumann Manufacturing Neodent GM Mini Conical Abutment - Product Usage: Mini Conical recall — FDA Z-0455-2019
Laser engraved label does not match with the item in the package
Class IIFDA: TerminatedStraumann Manufacturing, Inc.
Medical DeviceNov 21, 2018
American Contract Systems Powdered Surgical Gloves, labeled as: a recall — FDA Z-0456-2019
Powdered Surgical Gloves are an FDA banned substance.
Class IIFDA: TerminatedAmerican Contract Systems, Inc.
Medical DeviceNov 21, 2018
Invivo Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 recall — FDA Z-0462-2019
The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the…
Class IIFDA: CompletedInvivo Corporation
Medical DeviceNov 21, 2018
AROA Biosurgery OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G recall — FDA Z-0417-2019
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Class IIFDA: TerminatedAROA Biosurgery, LTD.
Medical DeviceNov 21, 2018
AROA Biosurgery OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G recall — FDA Z-0425-2019
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that…
Class IIFDA: TerminatedAROA Biosurgery, LTD.
Medical DeviceNov 21, 2018
Collagen Matrix BioMend Extend, REF# 0142Z, Synthetic bone grafting material recall — FDA Z-0414-2019
There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only…
Class IIIFDA: TerminatedCollagen Matrix, 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.