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Showing 3501–3520 of 68218 results

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Carvedilol Tablets 25mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Class IIModerate

FDAJan 22, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 12.5mg (Glenmark) – Impurity Risk (2025)

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

Class IIModerate

FDAJan 22, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Bread Crumbs (La Fiesta) – Undeclared Sesame (2025)

Undeclared Allergen

Firm distributed a Bread Crumb product with undeclared allergen (Sesame) not on the label.

Class IHigh

FDAJan 22, 2025Nationwide• La Fiesta Food Products

Seasoned Bread Crumbs (La Fiesta) – Undeclared Sesame (2025)

Undeclared Allergen

Firm distributed a Seasoned Bread Crumb product with undeclared allergen (Sesame) not on the label.

FDAJan 22, 2025Nationwide• La Fiesta Food Products

A.L.P.S. Anatomic Fibula Plate (Tyber) – screw placement risk (2025)

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

FDAJan 21, 2025Nationwide• Tyber Medical

A.L.P.S. Lateral Fibula Plate (Tyber) – screw placement risk (2025)

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

FDAJan 21, 2025Nationwide• Tyber Medical

LIFEPAK 15 Masimo Sensors (Physio-Control) – sensor error (2025)

Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.

FDAJan 21, 2025Nationwide• Physio-Control, Inc.

LIFEPAK 35 ECG Cable (Physio-Control) – incorrect instructions (2025)

Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions

FDAJan 21, 2025Nationwide• Physio-Control, Inc.

A.L.P.S. Medial Tibia Plate (Tyber) – screw placement risk (2025)

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

FDAJan 21, 2025Nationwide• Tyber Medical

Lorazepam Tablets 1mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Phenylephrine Injection (Provepharm) – Particulate Matter (2025)

Presence of Particulate Matter.

FDAJan 21, 2025Nationwide• Provepharm Inc.

Lorazepam Tablets 0.5mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lorazepam Tablets 2mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

Class IIModerate

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Irbesartan Tablets 300mg (AvKARE) – Dissolution Issue (2025)

Out of Specification for Dissolution

Class IIModerate

FDAJan 21, 2025Nationwide• AvKARE

Colussi Cantuccini Chocolate Drops Cookies (D. Coluccio) – Undeclared Almonds (2025)

Undeclared Allergen

Contains undeclared visible almonds

Class IIModerate

FDAJan 21, 2025DE, FL, GA +4 more• D. Coluccio & Sons Inc.

A.L.P.S. Anatomic Fibula Plate (Tyber) – screw placement risk (2025)

Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices

FDAJan 21, 2025Nationwide• Tyber Medical

HPV Control Panel (Microbiologics) – quality control issue (2025)

Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.

FDAJan 20, 2025Nationwide• Microbiologics Inc

Mombo Vanilla Soft Serve Ice Cream Mix (Arizona Foods) – Undeclared Egg (2025)

Undeclared Allergen

Product may contain egg, an undeclared allergen.

FDAJan 19, 2025NV• Arizona Foods Group, Inc.

Idaho Pacific Fine Potato Flour (Idaho Pacific) – Undeclared Milk (2025)

Undeclared Milk

Potato flour item #20501 was recalled due to undeclared milk (between 13ppm and 17ppm).

Class IIModerate

FDAJan 18, 2025IL, IN, MI +1 more• Idaho Pacific Corporation

3M V.A.C. Wound Therapy System (KCI) – leak alarm issue (2025)

Due to increase in complaints related to leak alarms

FDAJan 17, 2025Nationwide• KCI USA, INC.

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