FoodMar 21, 2018
Plant Devas Blemish Face Care Kit recall — FDA F-0930-2018
FDA Office of Colors and Cosmetics sampled product and found virulent and excessive numbers of microorganisms.
Class IIFDA: TerminatedPlant Devas Inc.
Latest records
Latest recalls — page 1479
The newest recall records with useful source details are listed here.
FoodMar 21, 2018
ripple Chocolate Nutritious Pea Milk recall — FDA F-0921-2018
Firm recalled product after finding high levels of coliforms, as well as Serratia liquefaciens.
Class IIFDA: TerminatedRIPPLE FOODS PBC
DrugMar 21, 2018
HYDROMORPHONE HYDROCHLORIDE Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL recall — FDA D-0596-2018
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class IFDA: TerminatedPfizer Inc.
DrugMar 21, 2018
Sagent Pharmaceuticals methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per recall — FDA D-0587-2018
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class IIFDA: TerminatedSagent Pharmaceuticals Inc.
DrugMar 21, 2018
Sagent Pharmaceuticals methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per recall — FDA D-0588-2018
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class IIFDA: TerminatedSagent Pharmaceuticals Inc.
DrugMar 21, 2018
Valganciclovir Tablets, USP, 450 mg, 60-count bottle recall — FDA D-0601-2018
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir…
Class IIFDA: TerminatedHetero Labs Limited Unit V
DrugMar 21, 2018
Sagent Pharmaceuticals methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per recall — FDA D-0586-2018
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class IIFDA: TerminatedSagent Pharmaceuticals Inc.
DrugMar 21, 2018
Valacyclovir Tablets USP 1 gram, 30-count bottle recall — FDA D-0602-2018
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir…
Class IIFDA: TerminatedHetero Labs Limited Unit V
DrugMar 21, 2018
HYDROMORPHONE HYDROCHLORIDE Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL recall — FDA D-0597-2018
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class IFDA: TerminatedPfizer Inc.
DrugMar 21, 2018
Alva-Amco Pharmacal Companies Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal recall — FDA D-0589-2018
Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Class IIIFDA: TerminatedAlva-Amco Pharmacal Companies., Inc.
DrugMar 21, 2018
Dr. Reddy's Laboratories Clocortolone Pivalate Cream, 0.1%, 90-gram tube recall — FDA D-0598-2018
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
Class IIIFDA: TerminatedDr. Reddy's Laboratories, Inc.
Medical DeviceMar 14, 2018
Bausch & Lomb Inc Irb LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX) recall — FDA Z-0851-2018
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily…
Class IIFDA: TerminatedBausch & Lomb Inc Irb
Medical DeviceMar 14, 2018
Bausch & Lomb Inc Irb LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75PAR (6/BOX), REF/PRODUCT recall — FDA Z-0886-2018
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily…
Class IIFDA: TerminatedBausch & Lomb Inc Irb
Medical DeviceMar 14, 2018
Euro Diagnostica AB DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA recall — FDA Z-0929-2018
Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong…
Class IIFDA: TerminatedEuro Diagnostica AB
Medical DeviceMar 14, 2018
Bausch & Lomb Inc Irb LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX) recall — FDA Z-0894-2018
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily…
Class IIFDA: TerminatedBausch & Lomb Inc Irb
Medical DeviceMar 14, 2018
Bausch & Lomb Inc Irb LASEREDGE Knives, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519 recall — FDA Z-0858-2018
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily…
Class IIFDA: TerminatedBausch & Lomb Inc Irb
Medical DeviceMar 14, 2018
Synthes (USA) Products 2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part recall — FDA Z-0902-2018
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceMar 14, 2018
Ortho-Clinical Diagnostics VITROS Chemistry Products DAT Performance Verifier I in vitro recall — FDA Z-0911-2018
This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this…
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceMar 14, 2018
Roche Diagnostics cobas 8000 Modular Analyzer Series recall — FDA Z-0910-2018
A warning is being added to the cobas 6000 analyzer and the cobas 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance.
Class IIFDA: TerminatedRoche Diagnostics Corporation
Medical DeviceMar 14, 2018
Synthes (USA) Products 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number recall — FDA Z-0905-2018
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Class IIFDA: TerminatedSynthes (USA) Products LLC
Medical DeviceMar 14, 2018
Philips Medical Systems (Cleveland) Brilliance Big Bore Radiology CT with 4.2.0 software recall — FDA Z-0839-2018
Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to…
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceMar 14, 2018
Stryker StrykeFlow 2 System, labeled sterile recall — FDA Z-0835-2018
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Class IIFDA: TerminatedStryker Corporation
Medical DeviceMar 14, 2018
Bausch & Lomb Inc Irb LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX) recall — FDA Z-0855-2018
The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily…
Class IIFDA: TerminatedBausch & Lomb Inc Irb
Medical DeviceMar 14, 2018
Synthes (USA) Products 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part recall — FDA Z-0904-2018
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Class IIFDA: TerminatedSynthes (USA) Products LLC
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