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Showing 101–120 of 201 results

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Multi-Action Relief Drops (Kilitch Healthcare) – Non-Sterile (2023)

Non-Sterility

FDANov 13, 2023Nationwide• Kilitch Healthcare India Limited

EQUATE Hydration Eye Drops (Kilitch Healthcare) – non-sterile (2023)

Non-Sterility

FDANov 13, 2023Nationwide• Kilitch Healthcare India Limited

Leader Dry Eye Relief (Kilitch Healthcare) – non-sterile (2023)

Non-Sterility

Class IHigh

FDANov 13, 2023Nationwide• Kilitch Healthcare India Limited

CVS Health Gel Drops (Kilitch Healthcare) – Non-Sterile (2023)

Non-Sterility

FDANov 13, 2023Nationwide• Kilitch Healthcare India Limited

Target Lubricant Eye Drops (Kilitch Healthcare) – Non-Sterile (2023)

Non-Sterility

FDANov 13, 2023Nationwide• Kilitch Healthcare India Limited

Lubricant Eye Drops (Kilitch Healthcare) – non-sterile (2023)

Non-Sterility

FDANov 13, 2023Nationwide• Kilitch Healthcare India Limited

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.

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.

Eye Irritation 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.

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

DOP Hand Sanitizer (Omega & Delta) – Potency Concern (2023)

Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Class IIModerate

FDAOct 20, 2023IN, PR• Omega & Delta Co., Inc.

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

DOP Hand Sanitizer Original (Omega & Delta) – Potency Problem (2023)

Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Class IIModerate

FDAOct 20, 2023IN, PR• Omega & Delta Co., Inc.

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) – CGMP Issues (2023)

CGMP Deviations

Class IIModerate

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

Organic Castor Oil Eye Drops (Dr. Berne's) – CGMP deviation (2023)

CGMP Deviations

Class IIModerate

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

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

Non-Sterility

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

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