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Glimepiride Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Epinephrine Kit (Focus Health Group) – Incorrect Labeling (2023)

Labeling; Incorrect NDC number on outer carton of product.

Class IIILow

FDAMar 16, 2023Nationwide• Focus Health Group Inc

Keystone Cougar (Keystone) – missing emergency exit (2023)

Keystone RV Company (Keystone) is recalling certain 2022-2023 Cougar travel trailers. These vehicles may have been manufactured without an emergency exit window.

NHTSAMar 16, 2023Nationwide• KEYSTONE

BusPIRone Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Ford F-150 Lightning (Ford) – battery short-circuit risk (2023)

Fire/Burn Risk

Ford Motor Company (Ford) is recalling certain 2023 F-150 Lightning pickup trucks. The high-voltage battery pack may experience an electrical short-circuit when the battery is fully charged or near fully charged.

NHTSAMar 15, 2023Nationwide• FORD

Beckman Coulter Access Free T3 (Beckman Coulter) – test result issue (2023)

The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results generated on other platforms. This introduces a risk of the positive bias not being detected by QC with the potential that clinical correlation with other thyroid function tests will be inconsistent requiring additional testing; however the clinical assessment and treatment decisions are not made in isolation on a single test result especially, in the setting of thyroid function testing. False positive test results could lead to a euthyroid patient being interpreted clinically as having elevated thyroid function (hyperthyroid) or a hypothyroid patient being within the normal range. Such misdiagnoses may lead to inappropriate treatment of a euthyroid patient with anti-thyroid medications or hypothyroid patient not getting sufficient treatment since their free T3 test result demonstrates them to be in the euthyroid range.

FDAMar 15, 2023Nationwide• Beckman Coulter, Inc.

Alliance RV Valor (Alliance RV) – incorrect wheel assembly (2023)

Alliance RV, LLC (Alliance RV) is recalling certain 2023 Valor 21T15 travel trailers. The incorrect size wheel and tire assemblies were installed and may become overloaded.

NHTSAMar 15, 2023Nationwide• ALLIANCE RV

Maxi-Cosi Coral XP Child Seat (Maxi-Cosi) – inner carrier issue (2023)

Dorel Juvenile Group (Dorel) is recalling certain Maxi-Cosi Coral XP Rear-facing Infant Seats with model number IC313. The child seat inner carrier is not sufficient to restrain a child without the use of the outer carrier. As such, these child seats fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 213, "Child Restraint Systems."

NHTSAMar 14, 2023Nationwide• MAXI-COSI

Hamilton-C6 Ventilator (Hamilton Medical) – safety ventilation error (2023)

Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.

FDAMar 14, 2023Nationwide• Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland

Fleetwood Discovery (Fleetwood) – door lock issue (2023)

REV Recreation Group (REV) is recalling certain 2023 Fleetwood Bounder, Flair, Flex, Fortis, Southwind, Discovery, Discovery LXE, Frontier, Frontier GTX, Pace Arrow, Holiday Rambler Admiral, Eclipse, Invicta, Vacationer, Armada, Endeavor, Navigator, Nautica, and American Coach American Tradition motorhomes. The entry door latch may fail and not allow entry or exit.

NHTSAMar 14, 2023Nationwide• FLEETWOOD

Pantoprazole Tablets (Hetero USA) – Discoloration Issue (2023)

CGMP Deviations: Discoloration

Class IIModerate

FDAMar 14, 2023Nationwide• Hetero USA Inc

Dabigatran Etexilate Capsules (Ascend Laboratories) – Impurity Levels (2023)

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Class IIModerate

FDAMar 14, 2023Nationwide• Ascend Laboratories, LLC

Dabigatran Etexilate Capsules (Ascend Laboratories) – Impurity Levels (2023)

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Class IIModerate

FDAMar 14, 2023Nationwide• Ascend Laboratories, LLC

Atovaquone Oral Suspension 750mg (Camber) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.

Class IHigh

FDAMar 13, 2023Nationwide• Camber Pharmaceuticals Inc.

Ford F-59 (Ford) – brake caliper bolt issue (2023)

Ford Motor Company (Ford) is recalling certain 2022 F-53 and F-59 vehicles. The rear brake caliper attachment bolts may not be tightened correctly, which can allow the caliper to loosen and possibly damage the wheel or brake lines.

NHTSAMar 10, 2023Nationwide• FORD

Ford Bronco (Ford) – backup camera issue (2023)

Ford Motor Company (Ford) is recalling certain 2021-2022 Bronco vehicles equipped with 8-inch SYNC infotainment screens that were previously remedied under recall 22V-825. The rearview camera image may still be displayed after a backing event has ended. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 111, "Rear Visibility."

NHTSAMar 10, 2023Nationwide• FORD

Ford Maverick (Ford) – trailer taillight fault (2023)

Ford Motor Company (Ford) is recalling certain 2023 Maverick vehicles. A missing electrical circuit may cause the trailer taillights to not illuminate as intended when utilizing the vehicle trailer tow electrical connector. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 108, " Lamps, Reflective Devices, and Associated Equipment."

NHTSAMar 10, 2023Nationwide• FORD

Stryker MAKO Baseplate Trial (Howmedica) – incorrect size marking (2023)

Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

FDAMar 10, 2023Nationwide• Howmedica Osteonics Corp.

Input Output Module (Inpeco) – sample ID mis-association (2023)

Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can result in weakness, polyuria, ileus, psychiatric disturbances, cardiac arrhythmias, respiratory depression, and death. Abnormal sodium levels can result in CNS disturbances and disturbances of water balance. Abnormal chloride levels can lead to acid base disturbances which can lead to respiratory and cardiac compromise. The event may occur only if all the following conditions occurs in few milliseconds timeframe: - The module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the module buffer lane due to a malfunction of the divert gate Only in this specific scenario, the Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without any error message. The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the test orders not performed yet on Tube B. Inpeco has released a Technical Service Bulletin with the procedure to correctly update the firmware. The firmware upgrade will be performed by Field Service Engineers. A CAPA (Corrective Action Preventive Action) has been opened to deeply investigate the root cause and identify possible process lack in order to avoid reoccurrences.

FDAMar 10, 2023Nationwide• Inpeco S.A. Via San Gottardo 10 Lugano Switzerland

VITROS XT 7600 Integrated System (Ortho-Clinical Diagnostics) – MicroTip Pack Issue (2023)

MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

FDAMar 10, 2023Nationwide• Ortho-Clinical Diagnostics, Inc.

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