FoodFeb 14, 2018
Wienke Net Wt recall — FDA F-0719-2018
Jams and Jellies are made with butter which is not declared on the label.
Class IIFDA: TerminatedWienke LLC
February 2018 recalls — page 11
These records include useful source details for the selected month.
FoodFeb 14, 2018
Wienke Net Wt recall — FDA F-0736-2018
Jams and Jellies are made with butter which is not declared on the label.
Class IIFDA: TerminatedWienke LLC
DrugFeb 14, 2018
Teva Pharmaceuticals USA Fentanyl Transdermal System. 75 mcg/h recall — FDA D-0542-2018
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class IIIFDA: TerminatedTeva Pharmaceuticals USA
DrugFeb 14, 2018
Flawless Beauty Sterilized water for injections BP, 50 x 5 mL plastic ampules recall — FDA D-0332-2018
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with…
Class IIFDA: TerminatedFlawless Beauty LLC
DrugFeb 14, 2018
Mckesson Packaging Services Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL recall — FDA D-0338-2018
Subpotent Drug: Out of specification for assay (stability testing)
Class IIIFDA: TerminatedMckesson Packaging Services
DrugFeb 14, 2018
Flawless Beauty Saluta Glutathione Whitening kits recall — FDA D-0334-2018
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with…
Class IIFDA: TerminatedFlawless Beauty LLC
DrugFeb 14, 2018
Flawless Beauty TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg recall — FDA D-0335-2018
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with…
Class IIFDA: TerminatedFlawless Beauty LLC
DrugFeb 14, 2018
Flawless Beauty Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche recall — FDA D-0327-2018
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with…
Class IIFDA: TerminatedFlawless Beauty LLC
DrugFeb 14, 2018
Teva Pharmaceuticals USA Fentanyl Transdermal System, 50 mcg/h recall — FDA D-0541-2018
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class IIIFDA: TerminatedTeva Pharmaceuticals USA
DrugFeb 14, 2018
Teva Pharmaceuticals USA Fentanyl Transdermal System, 100 mcg/h recall — FDA D-0543-2018
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class IIIFDA: TerminatedTeva Pharmaceuticals USA
DrugFeb 14, 2018
Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial recall — FDA D-0340-2018
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Class IFDA: TerminatedAuroMedics Pharma LLC
DrugFeb 14, 2018
Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible recall — FDA D-0337-2018
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Class IFDA: TerminatedAuroMedics Pharma LLC
DrugFeb 14, 2018
Flawless Beauty Reiki Glutathione Whitening kits recall — FDA D-0330-2018
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with…
Class IIFDA: TerminatedFlawless Beauty LLC
DrugFeb 14, 2018
Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 recall — FDA D-0339-2018
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Class IFDA: TerminatedAurobindo Pharma Ltd.
DrugFeb 14, 2018
Flawless Beauty Laennec INJ, Placenta extract (human), 2mL vials recall — FDA D-0329-2018
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with…
Class IIFDA: TerminatedFlawless Beauty LLC
DrugFeb 14, 2018
Teva Pharmaceuticals USA Fentanyl Transdermal System. 25 mcg/h recall — FDA D-0540-2018
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class IIIFDA: TerminatedTeva Pharmaceuticals USA
DrugFeb 14, 2018
Millennium Pharmaceuticals VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution recall — FDA D-0425-2018
Defective Container: Confirmed reports of loose vial crimps.
Class IIFDA: TerminatedMillennium Pharmaceuticals Inc.
DrugFeb 14, 2018
Ciclopirox Olamine Cream USP, 0.77% recall — FDA D-0250-2018
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Class IIIFDA: TerminatedG & W Laboratories, Inc.
DrugFeb 14, 2018
Flawless Beauty Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan recall — FDA D-0326-2018
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with…
Class IIFDA: TerminatedFlawless Beauty LLC
DrugFeb 14, 2018
Aripiprazole Tablets, USP, 10 mg, 30-count bottles recall — FDA D-0594-2018
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Class IIFDA: TerminatedHetero Labs, Ltd. - Unit III
DrugFeb 14, 2018
Flawless Beauty Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg recall — FDA D-0324-2018
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with…
Class IIFDA: TerminatedFlawless Beauty LLC
DrugFeb 14, 2018
Flawless Beauty Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione recall — FDA D-0328-2018
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with…
Class IIFDA: TerminatedFlawless Beauty LLC
DrugFeb 14, 2018
Flawless Beauty Relumins Vitamin C Solvent ampules recall — FDA D-0325-2018
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with…
Class IIFDA: TerminatedFlawless Beauty LLC
DrugFeb 14, 2018
Flawless Beauty TP Drug Laboratories Vitamin C ampules recall — FDA D-0331-2018
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with…
Class IIFDA: TerminatedFlawless Beauty LLC
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.