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Liothyronine Sodium Tablets (Sun Pharmaceutical) – Impurity Specs (2023)

Failed Impurities/Degradation Specifications.

FDAOct 20, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

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.

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Liothyronine Sodium Tablets (Sun Pharmaceutical) – Impurity Specs (2023)

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

Tiglutik Oral Suspension (ITF Pharma) – Viscosity Failure (2023)

Amazon Fresh Mini Brownie (Give and Go) – Potential Plastic Pieces (2023)

Liothyronine Sodium Tablets 5mcg (Sun) – impurity specification (2023)

Deferasirox Oral Suspension (Glenmark) – failed dissolution (2023)

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

Oxybutynin Chloride 10mg Tablets (Zydus) – Dissolution Failure (2023)

FYI ULTRA Joint Formula (Garden of Life) – Undeclared Soy (2023)

Oxybutynin Chloride 15mg Tablets (Zydus) – Dissolution Failure (2023)

RM-10 Mushroom Caplets (Garden of Life) – Undeclared Soy (2023)

Dark Chocolate Chip Waffles (Nature's Path) – Undeclared Peanut (2023)

Oxybutynin Chloride 5mg Tablets (Zydus) – Dissolution Failure (2023)

Strong Iodine Solution (Safecor Health) – CGMP Deviation (2023)

RM-10 ULTRA Immune Support (Garden of Life) – Undeclared Soy (2023)

Pumpkin Spice Waffles (Nature's Path) – Undeclared Peanut (2023)

Biochem HSC 70-LV Sanitizer (Integrity) – Chemical Levels (2023)

Biochem HSC 70-LM Sanitizer (Integrity) – Chemical Levels (2023)

Biochem HSC 70-VA Sanitizer (Integrity) – Chemical Levels (2023)

Hot & Spicy Cajun Seasoning (Asenzya) – Contains Sesame (2023)