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Showing 4821–4840 of 29086 results

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Hydrogen Peroxide 3% Solution (Vi-Jon) – Cross Contamination (2022)

Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.

Class IIModerate

FDAJun 28, 2022Nationwide• Vi-Jon, LLC

Launch Sequence Aphrodisia Capsules (Loud Muscle Science) – Unapproved Drug (2022)

Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.

Class IIModerate

FDAJun 27, 2022Nationwide• Loud Muscle Science

Launch Sequence Euphoria Capsules (Loud Muscle Science) – Unapproved Drug (2022)

Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.

Class IIModerate

FDAJun 27, 2022Nationwide• Loud Muscle Science

Divalproex Sodium Tablets 500mg (Sun Pharmaceutical) – Dissolution Failure (2022)

Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.

Class IIModerate

FDAJun 27, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Launch Sequence Capsules (Loud Muscle Science) – Unapproved Drug (2022)

Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.

Class IIModerate

FDAJun 27, 2022Nationwide• Loud Muscle Science

Daytrana Patch (Noven) – Delivery System Defect (2022)

Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.

Class IIModerate

FDAJun 24, 2022Nationwide• Noven Pharmaceuticals Inc

Hydrogen Peroxide Solution (Vi-Jon) – Labeling Mix-Up (2022)

Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.

Class IIModerate

FDAJun 24, 2022Nationwide• Vi-Jon, LLC

Slap Ya Mama Cajun Fish Fry (Walker & Sons) – wheat allergen (2022)

Undeclared Allergen

Undeclared Wheat Allergen

Class IIModerate

FDAJun 23, 2022GA, TN, TX• Walker & Sons Inc

A&D Prevention Ointment (Family Dollar) – temperature storage issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

READY IN CASE RUBBING ALCOHOL 91 PCT 16 FL OZ SKU 902270... (Family Dollar Stores, Llc.) – cgmp deviations: product held outside... (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Ready in Case Allergy Tablets (Family Dollar) – Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

ZzzQuil Night Pain Berry (Family Dollar) - Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Excedrin Migraine Caplets (Family Dollar) - Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Dulcolax Tablets (Family Dollar) – Storage Temperature (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Anti-Diarrheal Loperamide Caplets (Family Dollar) - Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Dermasil Dry Skin Treatment (Family Dollar) – temperature storage issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Carmex Daily Care Lip Balm (Family Dollar) - Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Swan Povidone Solution (Family Dollar) – Storage Temperature Deviation (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

DESITIN CREAMY OINTMENT 2 FL OZ SKU 912976 BABY LOVE OI... (Family Dollar Stores, Llc.) – cgmp deviations: product held outside... (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

Suave Invisible Solid Powder (Family Dollar) - Temperature Storage Issue (2022)

CGMP Deviations: product held outside appropriate storage temperature conditions.

Class IIModerate

FDAJun 23, 2022Nationwide• Family Dollar Stores, Llc.

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