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Showing 4301–4320 of 29086 results

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Menastil Homeopathic Formula (Atlantic) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 12, 2022Nationwide• Atlantic Management Resources Ltd.

Elsa Kolo Yegbes Kolo (Ebenezer) – improper labeling (2022)

Product was not properly labeled in English for importing into the US and filth was found in product (including mold, hair, bird feather, yarn).

Class IIModerate

FDADec 12, 2022MN• Ebenezer Ethio Market, LLC.

Alcohol Antiseptic Hand Sanitizer (NCH) – Impurity Levels (2022)

CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.

Class IIModerate

FDADec 9, 2022Nationwide• NCH Life Sciences LLC

Thiamine Hydrochloride Injection (McGuff) – Particulate Matter (2022)

Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.

Class IIModerate

FDADec 8, 2022Nationwide• McGuff Compounding Pharmacy Services, Inc.

Thiamine Hydrochloride 3000 mg (McGuff) – Foreign Substance (2022)

Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.

Class IIModerate

FDADec 8, 2022Nationwide• McGuff Compounding Pharmacy Services, Inc.

King Oscar Anchovies (Tri-Union) – Histamine Levels (2022)

Anchovies found to have elevated levels of histamine

Class IIModerate

FDADec 7, 2022IL, NH, DC• Tri-Union Frozen Products Inc

Nice List Eggnog (Hartzler Dairy) – Mislabeled Product (2022)

Mislabeled products; product did not have the ingredients list listed.

Class IIModerate

FDADec 7, 2022KY, OH• Hartzler Family Dairy

Quinapril Tablets 40mg (Lupin) – Impurity Limit Exceeded (2022)

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Class IIModerate

FDADec 7, 2022Nationwide• Lupin Pharmaceuticals Inc.

Quinapril Tablets 20mg (Lupin) – Impurity Limit Exceeded (2022)

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Class IIModerate

FDADec 7, 2022Nationwide• Lupin Pharmaceuticals Inc.

Garlic Frozen Pizza Dough (It'll Be Pizza) – Foreign Object (2022)

Product may be contaminated with foreign object (debris from packaging).

Class IIModerate

FDADec 6, 2022ME, MA, NH +2 more• It'll Be Pizza, LLC.

EGA Pizza Dough Balls (It'll Be Pizza) – Foreign Object (2022)

Product may be contaminated with foreign object (debris from packaging).

Class IIModerate

FDADec 6, 2022ME, MA, NH +2 more• It'll Be Pizza, LLC.

Brava Pizza Dough (It'll Be Pizza) – Foreign Object (2022)

Product may be contaminated with foreign object (debris from packaging).

Class IIModerate

FDADec 6, 2022ME, MA, NH +2 more• It'll Be Pizza, LLC.

Blonde Frozen Pizza Dough (It'll Be Pizza) – Foreign Object (2022)

Product may be contaminated with foreign object (debris from packaging).

Class IIModerate

FDADec 6, 2022ME, MA, NH +2 more• It'll Be Pizza, LLC.

Take 2 Classic Pizza Dough (It'll Be Pizza) – Foreign Object (2022)

Product may be contaminated with foreign object (debris from packaging).

Class IIModerate

FDADec 6, 2022ME, MA, NH +2 more• It'll Be Pizza, LLC.

Circle K Pizza Dough (It'll Be Pizza) – Foreign Object (2022)

Product may be contaminated with foreign object (debris from packaging).

Class IIModerate

FDADec 6, 2022ME, MA, NH +2 more• It'll Be Pizza, LLC.

Beer Frozen Pizza Dough (It'll Be Pizza) – Foreign Object (2022)

Product may be contaminated with foreign object (debris from packaging).

Class IIModerate

FDADec 6, 2022ME, MA, NH +2 more• It'll Be Pizza, LLC.

Beijing Hawthorne Candy (Northern Food) – Undeclared Sulfites (2022)

Undeclared Allergen

Product contains undeclared sulfites (7.32 mg/serving)

Class IIModerate

FDADec 5, 2022CA, CO, CT +21 more• Northern Food I/E Inc.

Desmopressin Acetate Tablet (RemedyRepack) – Subpotent Drug (2022)

Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.

Class IIModerate

FDADec 5, 2022IN, MI• RemedyRepack Inc.

TUMS Antacid Berries (GSK) – Glass Mineral Contamination (2022)

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Class IIModerate

FDADec 2, 2022Nationwide• GlaxoSmithKline Consumer Healthcare Holdings LLC

TUMS Antacid Peppermint (GSK) – Glass Mineral Contamination (2022)

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Class IIModerate

FDADec 2, 2022Nationwide• GlaxoSmithKline Consumer Healthcare Holdings LLC

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