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Showing 21–40 of 201 results

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Carboxymethylcellulose Eye Solution (BRS Analytical) - Sterility Concern (2025)

cGMP deviations and lack of assurance of sterility.

Class II

FDAApr 23, 2025Nationwide• BRS Analytical Services, LLC

Artificial Tears Solution (BRS Analytical) - Sterility Concern (2025)

cGMP deviations and lack of assurance of sterility.

Class II

FDAApr 23, 2025Nationwide• BRS Analytical Services, LLC

Polyvinyl Alcohol Eye Drops (BRS Analytical) - Sterility Concern (2025)

cGMP deviations and lack of assurance of sterility.

Class II

FDAApr 23, 2025Nationwide• BRS Analytical Services, LLC

Erin's Faces Mineral SPF 32 (Kabana) – cGMP Deviations (2025)

cGMP deviations

Class II

FDAMar 12, 2025FL, MI, NJ• KABANA SKIN CARE

In Your Face Mineral Tint SPF 31 (Kabana) – cGMP Deviations (2025)

cGMP deviations

Class II

FDAMar 12, 2025FL, MI, NJ• KABANA SKIN CARE

B Natural Organics Sunscreen (Kabana) – cGMP Deviations (2025)

cGMP deviations

Class II

FDAMar 12, 2025FL, MI, NJ• KABANA SKIN CARE

Hydrogen Peroxide Solution (Consumer Product) – Label Mixup (2025)

Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol

Class II

FDAMar 7, 2025VA• Consumer Product Partners, LLC

Tropicamide Ophthalmic Solution (Imprimis) – Sub-Potent Drug (2025)

Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.

Class III

FDAFeb 24, 2025FL, NY• Imprimis NJOF, LLC

Iodo Blanco Antiseptic (World Perfumes) – Container Defect (2025)

Defective Container: broken or leaking bottles.

Class II

FDAFeb 13, 2025FL• World Perfumes Inc.

Mineral Sunscreen (Babyganics) – Chemical Contamination (2025)

Chemical Contamination

Class II

FDAFeb 13, 2025Nationwide• Johnson, S C and Son, Inc

Mineral Sunscreen (Babyganics) – Chemical Contamination (2025)

Chemical Contamination

Class II

FDAFeb 13, 2025Nationwide• Johnson, S C and Son, Inc

Alprostadil (Aspen Biopharma) – CGMP Issues (2025)

CGMP Deviations

Class II

FDAFeb 7, 2025FL, IN• Aspen Biopharma Labs Pvt., Ltd.

Latanoprost (Aspen Biopharma) – CGMP Deviation (2025)

CGMP Deviations

Class II

FDAFeb 7, 2025FL, IN• Aspen Biopharma Labs Pvt., Ltd.

SinuCleanse Soft Tip Bottle (Ascent) – Bacterial Contamination (2025)

Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus

Class I

FDAJan 28, 2025Nationwide• Ascent Consumer Products Inc.

Madras Curry Powder (Trong Food) – Lead Contamination (2025)

Elevated levels of lead 5.48mg/kg and 2.59mg/kg in (2) lots of Madras Curry Powder.

Class II

FDAJan 28, 2025IN, MD, WA +1 more• Trong Food International

Shatavari Powder (Zaarah Herbals) – Lead Contamination (2025)

Product contains elevated levels of lead - 6.50 mg/kg (ppm)

Class I

FDAJan 27, 2025CA, CT, NJ +1 more• NEW YORK WHOLESALE GROUP

Babyganics Sunscreen (Johnson) – Ingredient Separation (2025)

Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.

Class II

FDAJan 8, 2025Nationwide• Johnson, S C and Son, Inc