FoodApr 19, 2017
Dolcetta Artisan Sweets Peanut Crisp Truffles are milk chocolate with peanut butter recall — FDA F-1941-2017
undeclared soy lecithin.
Class IIFDA: TerminatedDolcetta Artisan Sweets
Latest records
Latest recalls — page 1658
The newest recall records with useful source details are listed here.
FoodApr 19, 2017
Dolcetta Artisan Sweets Rosemary Caramel Bar is dark chocolate with rosemary infused recall — FDA F-1943-2017
undeclared soy lecithin and milk (cream and butter were declared).
Class IIFDA: TerminatedDolcetta Artisan Sweets
FoodApr 19, 2017
J & J Distributing Company Kowalski's Markets, Protein Powerhouse, UPC 6-10014-14692-4, 8 recall — FDA F-1919-2017
J&J Distributing Company reported that a small amount of shred carrots were contaminated with metal pieces. The shred carrots were used as ingredient for other RTE items.
Class IIFDA: TerminatedJ & J Distributing Company
FoodApr 19, 2017
Pro Sports Club 20/20 LifeStyles Yogurt Peanut Crunch Bar recall — FDA F-1913-2017
Product is recalled due to a potential contamination with E. coli O157:H7.
Class IFDA: TerminatedPro Sports Club
FoodApr 19, 2017
J & J Distributing Company Mix General Tso Chik, 2 lbs Food service plastic bag for Food recall — FDA F-1916-2017
J&J Distributing Company reported that a small amount of shred carrots were contaminated with metal pieces. The shred carrots were used as ingredient for other RTE items.
Class IIFDA: TerminatedJ & J Distributing Company
FoodApr 19, 2017
Lian Hwa Foods (USA) Good Plenty Brand Supreme Abalone Noodles, 21.2 oz recall — FDA F-1900-2017
During an FDA foreign inspection, it was discovered that Wheat was not properly declared on the product labeling. Wheat is an ingredient in the noodles contained in the product. Wheat is…
Class IIIFDA: TerminatedLian Hwa Foods (USA) Inc.
DrugApr 19, 2017
Medisca ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06) recall — FDA D-0664-2017
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class IIFDA: TerminatedMedisca, Inc.
DrugApr 19, 2017
Jubilant Cadista Pharmaceuticals BuPROPion Hydrochloride Extended-release Tablets, USP (SR) recall — FDA D-0671-2017
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class IIIFDA: TerminatedJubilant Cadista Pharmaceuticals, Inc.
DrugApr 19, 2017
Medisca ESTRADIOL, USP Bulk (Hemihydrate), in a) 25 g (NDC 38779-2261-04) and b) 100 g recall — FDA D-0666-2017
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class IIFDA: TerminatedMedisca, Inc.
DrugApr 19, 2017
West-Ward Columbus Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only recall — FDA D-0651-2017
Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
Class IIIFDA: TerminatedWest-Ward Columbus, Inc.
DrugApr 19, 2017
Jubilant Cadista Pharmaceuticals BuPROPion Hydrochloride Extended-release Tablets, USP (SR) recall — FDA D-0669-2017
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class IIIFDA: TerminatedJubilant Cadista Pharmaceuticals, Inc.
DrugApr 19, 2017
Medisca ESTRIOL, USP (Micronized) Bulk, in a) 5 grams (NDC 38779-0732-03), b) 25 grams recall — FDA D-0663-2017
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class IIFDA: TerminatedMedisca, Inc.
DrugApr 19, 2017
Medisca ESTRADIOL, USP (Hemihydrate)(Micronized), in a) 100 mg (NDC 38779-0869-07), b) 1 g recall — FDA D-0665-2017
cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class IIFDA: TerminatedMedisca, Inc.
DrugApr 19, 2017
Signature Club A Double Hyaluronic 1000, 'AN OUNCE OF GOLD' Volumizing Day Cream, Broad recall — FDA D-0662-2017
Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
Class IIFDA: OngoingSignature Club A Ltd
DrugApr 19, 2017
hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial recall — FDA D-0668-2017
Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.
Class IIFDA: TerminatedMckesson Medical Surgical
DrugApr 19, 2017
Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles recall — FDA D-0652-2017
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Class IIIFDA: TerminatedCitron Pharma LLC
DrugApr 19, 2017
Jubilant Cadista Pharmaceuticals BuPROPion Hydrochloride Extended-release Tablets, USP (SR) recall — FDA D-0670-2017
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Class IIIFDA: TerminatedJubilant Cadista Pharmaceuticals, Inc.
Medical DeviceApr 12, 2017
Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item recall — FDA Z-1744-2017
Product sterility is compromised due to breach of sterile barrier
Class IIFDA: TerminatedCovidien LLC
Medical DeviceApr 12, 2017
Centurion Medical Products OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are recall — FDA Z-1731-2017
Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier's recall because of potential breach in sterile packaging.
Class IIFDA: TerminatedCenturion Medical Products Corporation
Medical DeviceApr 12, 2017
Intuitive Surgical STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model recall — FDA Z-1729-2017
Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result…
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceApr 12, 2017
Centurion Medical Products EYE KIT The Covidien Curity Oval Eye Pads are individually recall — FDA Z-1733-2017
Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier's recall because of potential breach in sterile packaging.
Class IIFDA: TerminatedCenturion Medical Products Corporation
Medical DeviceApr 12, 2017
Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR recall — FDA Z-1749-2017
Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceApr 12, 2017
Philips Medical Systems (Cleveland) BrightView SPECT model number 882480 BrightView and recall — FDA Z-1750-2017
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
Class IIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.
Medical DeviceApr 12, 2017
Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for recall — FDA Z-1747-2017
Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
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