Schlotterbeck &amp; Foss, LLC Recalls

Contains undeclared fish

FDAMar 20, 2021ME, NC• Schlotterbeck & Foss, LLC

Evrysdi Prescription Drug (Genentech) – Packaging Issue (2021)

This recall involves bottles of the prescription drug Evrysdi, a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older. The recalled 100 mL amber bottles have "Evrysdi (risdiplam) for oral solution," the dosage and "NDC 20242-175-07" on the front of the bottle labels.

CPSCMar 18, 2021Nationwide• Genentech, a member of the Roche Group, of South San Francisco, Calif.

Sight OLO-E1/U1 Software (Sight Diagnostics) – Labeling Discrepancy (2021)

Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software

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FDAMar 17, 2021Nationwide• SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel

Durisan Sanitizing Wipes (Sanit) – manufacturing deviation (2021)

CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.

FDAMar 10, 2021Nationwide• Sanit Technologies, LLC dba Durisan

Durisan Hand Sanitizer (Sanit) – microbial contamination (2021)

Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.

FDAMar 10, 2021Nationwide• Sanit Technologies, LLC dba Durisan

Durisan Antimicrobial Solutions (Sanit) – manufacturing deviation (2021)

CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.

FDAMar 10, 2021Nationwide• Sanit Technologies, LLC dba Durisan

Durisan Sanitizing Wipes (Sanit) – microbial contamination (2021)

Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.

FDAMar 10, 2021Nationwide• Sanit Technologies, LLC dba Durisan

RayCare 3B (3.1.0.60341) - Product Usage: Intended Use On... (RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden) – patient related messages created in r... (2021)

Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later

FDAMar 3, 2021Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

RayStation Software (RaySearch) – Dose Labeling Error (2021)

For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.

FDAFeb 22, 2021Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Power Max Snowthrowers (Toro) – Amputation Hazard (2021)

This recall involves Model Year 2021 Toro Power Max 826 OHAE Snowthrowers with Model Number 37802. The model and serial number are located on the back of the snowthrower. Serial numbers included in this recall are listed on Toro's website at https://www.toro.com/en/product-safety-information/product-recall-information.

CPSCFeb 17, 2021Nationwide• The Toro Company, of Bloomington, Minn.

Shannon Percutaneous Burr (In2Bones) – Manufacturing Nonconformity (2021)

This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use.

FDAFeb 9, 2021Nationwide• In2Bones, SAS 28 Chemin du petit Bois Ecully France

Dole Chopped Kit (Dole) – Undeclared Allergens (2021)

Potential undeclared allergens (wheat and tree nuts)

FDAFeb 9, 2021NY, OH, WI• Dole Fresh Vegetables Inc

Thread-Like Wire Marker (Somatex) – Wire Splintering Risk (2021)

This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the patient's body.

FDAFeb 3, 2021MO, NJ, OH• Somatex Medical Technologies GMBH Hohenzollerndamm 150-151 Berlin Germany

Vanilla Yogurt Cranberries (Ohio Hickory Harvest) – undeclared almonds (2021)

Undeclared Allergen of Tree Nuts : Almonds

FDAFeb 2, 2021IN, TX• Ohio Hickory Harvest Brand Products, Inc.

Auryxia (Akebia) – dissolution failure (2021)

Failed Dissolution Specifications

Class IIILow

FDAJan 29, 2021Nationwide• Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Endless Summer Salad Kit (Dole Fresh Vegetables) – mislabeled dressing (2021)

Two consumer complaints received for incorrect Master pack in Endless Summer salad kit - undeclared fish and eggs in Caesar dressing that was inadvertently included.

FDAJan 28, 2021AZ, CA, CO +14 more• Dole Fresh Vegetables Inc

Spironolactone Tablets (Bryant Ranch) – Label Mix-Up (2021)

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.

FDAJan 27, 2021Nationwide• Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Spironolactone Tablets (Bryant Ranch) – Label Mix-Up (2021)

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets.