Recall

All recalls7,877 total

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Santa Monica Seafood Company — Atlantic Salmon Portions with Seafood Stuffing; 16 OZ (1 LB) 454g; Use/Freeze By: JUN.02.25; UPC: 4061459716313

Atlantic Salmon Portions with Seafood Stuffing was incorrectly labeled and does not declare allergen ingredient (SOY)

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Ascend Laboratories, LLC — Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC

Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.

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Ascend Laboratories, LLC — Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC

Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.

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GE Medical Systems, LLC — SIGNA Architect

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

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GE Medical Systems, LLC — SIGNA Architect AIR

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

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GE Medical Systems, LLC — SIGNA PET/MR

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

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GE Medical Systems, LLC — Discovery MR750w 3.0T

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

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Steris Corporation — Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.

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Aurobindo Pharma USA Inc — Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).

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LTS Therapy Systems, LLC — IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.

The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

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LTS Therapy Systems, LLC — IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.

The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

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Albertsons Companies LLC — AMCE GREEK SALAD AUTHENTIC FS, Refrigerated, packaged in clear plastic container, sold by pound, UPC 293070 ##### READY MEALS GREEK SALAD SS, Refrigerated, packaged in clea

Salmonella. Greek Salad products were made with recalled cucumbers from Bedner Grower's Company which are contaminated with Salmonella and implicated in an ongoing outbreak.

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Reser's Fine Foods, Inc. dba Fresh Creative Foods — Lancaster LF Authentic Greek Salad Kit, 2/7.125lb. packages, net wt. 14.25lb., Item Code 407079, UPC 13454.38482. This is wholesale kit consistin

Salmonella. Greek Salad Kit made with recalled cucumbers sourced from Bedner Grower's Company which may be contaminated with Salmonella and implicated in an ongoing outbreak.

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Umary-USA.com — UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295

Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.

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Umary-USA.com — UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134

Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.

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