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Showing 721–740 of 3363 results

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Rugby Allergy Decongestant (Dr. Reddy's) – Dissolution Failure (2022)

Failed Dissolution Specifications

FDAJan 4, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Rite Aid Allergy Relief (Dr. Reddy's) – Dissolution Failure (2022)

Failed Dissolution Specifications

FDAJan 4, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

CVS Allergy Relief D (Dr. Reddy's) – Dissolution Failure (2022)

Failed Dissolution Specifications

Class IIILow

FDAJan 4, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Equate Allergy Relief D (Dr. Reddy's) – Dissolution Failure (2022)

Failed Dissolution Specifications

FDAJan 4, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Dr. Reddys Allergy Medication (Dr. Reddy's) – Dissolution Failure (2022)

Failed Dissolution Specifications

FDAJan 4, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Leader Allergy Relief (Dr. Reddy's) – Dissolution Failure (2022)

Failed Dissolution Specifications

FDAJan 4, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Wal-Fex D (Dr. Reddy's) – Dissolution Failure (2022)

Failed Dissolution Specifications

FDAJan 4, 2022Nationwide• Dr. Reddy's Laboratories, Inc.

Oxycodone Tablets (Lupin) – Impurity Test Failure (2021)

Out-of-specification impurity test result observed at 18-month long term stability time point.

FDADec 29, 2021IN, NY, OH• Lupin Pharmaceuticals Inc.

Gatifloxacin Ophthalmic Solution (Lupin) – Stability Failure (2021)

Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.

FDADec 22, 2021Nationwide• Lupin Pharmaceuticals Inc.

Tartar Sauce (Beaver Brand) – Undeclared soy (2021)

Undeclared soy in Tartar sauce. Ingredients statement declares soybean oil.

FDADec 21, 2021IN, OR, SC• Beaverton Foods Inc

Seafood Tartar Sauce (Inglehoffer) – Undeclared soy (2021)

Undeclared soy in Tartar sauce. Ingredients statement declares soybean oil.

FDADec 21, 2021IN, OR, SC• Beaverton Foods Inc

Fish-Pickle (Aroma Meats) – Fish name undeclared (2021)

Fish is declared but specific fish name is not declared on Fish-pickle.

FDADec 18, 2021IN, OR• Aroma Meats LLC

Happi Foodi Roasted Russets (Prepared Meals) – Mold Contamination (2021)

Presence of visible mold detected.

FDADec 8, 2021CA• Prepared Meals Co

CTx36 Kit (Dental Alliance) - Low Sodium Fluoride (2021)

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

FDADec 3, 2021Nationwide• Dental Alliance Holdings LLC

Oxycodone Hydrochloride Solution (Akorn) - Missing Label (2021)

Labeling: Missing Label

FDADec 3, 2021Nationwide• Akorn, Inc.

CariFree CTx4 Gel 5000 (Dental Alliance) - Low Sodium Fluoride (2021)

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

FDADec 3, 2021Nationwide• Dental Alliance Holdings LLC

CTx26 Kit (Dental Alliance) – Insufficient Sodium Fluoride (2021)

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

FDADec 3, 2021Nationwide• Dental Alliance Holdings LLC

CTx21 Kit (Dental Alliance) - Low Sodium Fluoride (2021)

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

FDADec 3, 2021Nationwide• Dental Alliance Holdings LLC

Morphine Sulfate Oral Solution (Akorn) – Missing Label Information (2021)

Labeling: Missing Label

FDADec 3, 2021Nationwide• Akorn, Inc.

CTx7 Kit (Dental Alliance) – Insufficient Sodium Fluoride (2021)

Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

FDADec 3, 2021Nationwide• Dental Alliance Holdings LLC

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