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Showing 1–19 of 19 results

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ReadyPrep PVP Povidone-Iodine (Medline Industries) - Subpotent Drug (2025)

Subpotent drug

FDAAug 19, 2025Nationwide• Medline Industries, LP

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.

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

Carboxymethylcellulose Eye Drops (AvKARE) – label mix-up (2024)

LABELING: LABEL MIX-UP

Class III

FDADec 18, 2024Nationwide• AvKARE

Polyvinyl Alcohol Eye Drops (AvKARE) – label mix-up (2024)

LABELING: LABEL MIX-UP

FDADec 18, 2024Nationwide• AvKARE

Kids Cough Medicine (Denison) – Crystallization Issue (2024)

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

FDASep 25, 2024Nationwide• Denison Pharmaceuticals, LLC

Adult Cough Medicine (Denison) – Crystallization Issue (2024)

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

FDASep 25, 2024Nationwide• Denison Pharmaceuticals, LLC

MySyrup Sugar Free Vanilla (My Chai Inc) – Production Record Issue (2024)

Acidified product is recalled due to lack production record.

FDAAug 21, 2024Nationwide• My Chai Inc

MySyrup Sugar Free Caramel (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

FDAAug 21, 2024Nationwide• My Chai Inc

MySyrup Peppermint (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

FDAAug 21, 2024Nationwide• My Chai Inc

MySyrup Raspberry (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

FDAAug 21, 2024Nationwide• My Chai Inc

MySyrup Hazelnut (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

FDAAug 21, 2024Nationwide• My Chai Inc

MySyrup Coconut (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

FDAAug 21, 2024Nationwide• My Chai Inc

MySyrup Salted Caramel (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

FDAAug 21, 2024Nationwide• My Chai Inc

Oregon Orchards Banana Mix (My Chai) – Production Record (2024)

Acidified product is recalled due to lack production record.

FDAAug 21, 2024Nationwide• My Chai Inc

Hemp Bombs CBD Pain Freeze (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Nature's Script CBD Roll-On (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Hemp Bombs CBD Pain Freeze (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Hemp Bombs CBD Pain Freeze (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Ranitidine Tablets 150mg (AuroMedics) – Empty Bottles (2019)

CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

FDASep 23, 2019Nationwide• AuroMedics Pharma LLC