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Showing 41–59 of 59 results

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Dry Eye Relief (Leader) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

FDAOct 31, 2023Nationwide• Cardinal Health Inc.

Lubricant Eye Drops (Leader) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

FDAOct 31, 2023Nationwide• Cardinal Health Inc.

Lubricant Eye Drops (Leader) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

Class I

FDAOct 31, 2023Nationwide• Cardinal Health Inc.

Dry Eye Relief (Leader) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

FDAOct 31, 2023Nationwide• Cardinal Health Inc.

Lubricant Eye Drops (Leader) – non-sterile manufacturing (2023)

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

FDAOct 31, 2023Nationwide• Cardinal Health Inc.

Artri King Reforzado Tablets (Botanical Be) – Undeclared Ingredient (2023)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

FDAOct 20, 2023Nationwide• Botanical Be

Kuka Flex Forte Caplets (Botanical Be) – Undeclared Ingredient (2023)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

FDAOct 20, 2023Nationwide• Botanical Be

TheraBreath Kids Oral Rinse (Church & Dwight) – Microbial Contamination (2023)

Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis

FDASep 8, 2023Nationwide• Church & Dwight Inc

MSM DROPS 5% Solution (Dr. Berne's) – Non-Sterility (2023)

Non-Sterility

FDAAug 26, 2023Nationwide• Dr. Berne's Whole Health Products

MSM Drops (Pharmedica USA) – Non-Sterility Risk (2023)

Non-Sterility

FDAFeb 14, 2023Nationwide• Pharmedica USA, LLC

Delsam Artificial Tears (Global Pharma) – Bacterial Contamination (2023)

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

FDAJan 30, 2023Nationwide• Global Pharma Healthcare Private Limited

Artificial Tears Eye Drops (Global Pharma) – Bacterial Contamination (2023)

Non-Sterility: FDA analysis found unopened products to have bacterial contamination.

FDAJan 30, 2023Nationwide• Global Pharma Healthcare Private Limited

Hand Sanitizer (Adam's Polishes) – Chemical Contamination (2022)

Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.

FDANov 5, 2022Nationwide• Adam's Polishes LLC

Limar Hand Sanitizer (Ardil) – Misleading Packaging (2021)

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

FDAJun 22, 2021IN• Ardil Comercial S.R.L.

Medically Minded Hand Sanitizer (Global) - Low Alcohol Content (2021)

Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

FDAMay 12, 2021Nationwide• Global Sanitizers LLC

Hand Sanitizer Gel (Global Sanitizers) – Chemical Contamination (2021)

Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

FDAMay 12, 2021Nationwide• Global Sanitizers LLC

Real Alkalized Water (Real Water) – liver failure (2021)

Laceration Risk

FDA was notified of cases of acute liver failure after consumption of Real Water

FDAMar 17, 2021Nationwide• Real Water, Inc.

Real Alkalized Water Concentrate (Real Water) – liver failure (2021)

Laceration Risk

FDA was notified of cases of acute liver failure after consumption of Real Water

FDAMar 17, 2021Nationwide• Real Water, Inc.

ManukaGuard Nasal Spray (NDAL) – Microbial Contamination (2020)

Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast

FDADec 17, 2020Nationwide• NDAL Mfg Inc.

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