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Rye Loaf (Klosterman) – Unsanitary Conditions (2022)

Products held under insanitary conditions

Class IIModerate

FDADec 18, 2022IN, OH, TN• Klosterman Baking Company

Cuban Loaf (Klosterman) – Unsanitary Conditions (2022)

Products held under insanitary conditions

Class IIModerate

FDADec 18, 2022IN, OH, TN• Klosterman Baking Company

Seeded Buns (Klosterman) – Unsanitary Conditions (2022)

Products held under insanitary conditions

Class IIModerate

FDADec 18, 2022IN, OH, TN• Klosterman Baking Company

Ganciclovir Injection (Hikma) – Label Mix-up (2022)

Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.

Class IIModerate

FDADec 16, 2022Nationwide• Hikma Pharmaceuticals USA Inc.

Glycopyrrolate Tablets (Aurolife) – Impurity Specifications (2022)

Failed Impurities/Degradation Specifications

Class IIModerate

FDADec 16, 2022Nationwide• Aurolife Pharma, LLC

Oat Yogurt Alternative (Meijer) – Mislabeled Product (2022)

almond-based product was packaged in tubs labeled as oat-based with almond based lid

Class IIModerate

FDADec 16, 2022IL, IN, KY +3 more• Meijer Inc

Hickory Smoked Almonds (Woodland) – Undeclared Milk (2022)

Undeclared Milk

Undeclared milk

Class IIModerate

FDADec 16, 2022Nationwide• Woodland Foods LLC

Easy Clean Isopropyl Alcohol (Frenda) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 15, 2022PR• Frenda Corporation

Global Care Hand Sanitizer (Frenda) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 15, 2022PR• Frenda Corporation

Pierogi The Holy Gouda (Pietrzyk) – undeclared soy (2022)

Undeclared Soy

Undeclared soy lecithin

Class IIModerate

FDADec 15, 2022MI• Pietrzyk Foods

Easy Clean Surface Disinfectant (Frenda) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 15, 2022PR• Frenda Corporation

Global Care Rubbing Alcohol (Frenda) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 15, 2022PR• Frenda Corporation

Easy Clean Isopropyl Alcohol (Frenda) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 15, 2022PR• Frenda Corporation

Easy Clean Hand Sanitizer (Frenda) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 15, 2022PR• Frenda Corporation

Easy Clean Ethyl Alcohol (Frenda) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 15, 2022PR• Frenda Corporation

Pepper Collection Gift Set (Something SA) – mold contamination (2022)

Due to presence of mold (Aspergillus brasiliensis) and Ochratoxin A.

Class IIModerate

FDADec 12, 2022Nationwide• Something South African LLC

Rifampin Capsules (Lupin) – Impurity Specifications (2022)

Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.

Class IIModerate

FDADec 12, 2022Nationwide• Lupin Pharmaceuticals Inc.

Neuroquell Plus Homeopathic Drug (Atlantic) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 12, 2022Nationwide• Atlantic Management Resources Ltd.

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

cGMP Deviations

Class IIModerate

FDADec 12, 2022Nationwide• Atlantic Management Resources Ltd.

Neuroquell Homeopathic Drug (Atlantic) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 12, 2022Nationwide• Atlantic Management Resources Ltd.

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