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Levofloxacin Tablets (Macleods) – Embossing Mismatch (2023)

Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

Class IIILow

FDAJan 5, 2023Nationwide• MACLEODS PHARMA USA, INC

SINUVA Sinus Implant (Intersect ENT) – Failed Dissolution (2023)

Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.

Class IIILow

FDAJan 4, 2023Nationwide• Intersect ENT, Inc.

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Levofloxacin Tablets (Macleods) – Embossing Mismatch (2023)

SINUVA Sinus Implant (Intersect ENT) – Failed Dissolution (2023)

Prochlorperazine Tablets (Jubilant) – Subpotent Drug (2022)

Timolol Maleate (Apotex) – Stability Specification Failure (2022)

Lacosamide Oral Solution (Camber) – Excipient Specification Fail (2022)

Shirakiku Original Fish Sausage - Undeclared Collagen (2022)

Shirakiku Jalapeno Fish Sausage - Undeclared Collagen (2022)

Dole Southwest Salad Kit - Chemical Wash Issue (2022)

Marketside Southwest Chopped Salad (Dole) - Chemical Contamination (2022)

Dole Chopped Chipotle Cheddar Salad (Dole) - Chemical Contamination (2022)

Peak Harvest Bacon Sunflower Crunch Salad (Dole) - Chemical Contamination (2022)

Salad Blends American Style (Dole) - Chemical Contamination (2022)

Dole Chopped Buffalo Ranch Kit - Chemical Wash Issue (2022)

Little Salad Bar Asian Chopped Salad (Dole) - Chemical Contamination (2022)

Marketside Bacon Ranch Crunch Salad (Dole) - Chemical Contamination (2022)

Peak Harvest Bacon Avocado Ranch Salad (Dole) - Chemical Contamination (2022)

Dole Chopped Kit Avocado Ranch (Dole) - Chemical Contamination (2022)

Dole Chopped BBQ Ranch Kit - Chemical Wash Issue (2022)

Dole Diced Southern Slaw - Chemical Wash Issue (2022)

Dole Chopped Kit Bacon & Bleu - Chemical Wash Issue (2022)