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Showing 1261–1280 of 2326 results

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Burfi (BAPS Shayona) – undeclared soy (2023)

During an FDA inspection the firm was notified that some of their products contains undeclared soy.

Class IIModerate

FDAJul 27, 2023AL, FL, GA +3 more• BAPS Shayona

Testosterone Injection (New Vitalis) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 13, 2023Nationwide• New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Uro Kid Support Capsules (Global Vitality) – E. Coli Risk (2023)

potential contamination with E coli

Class IIModerate

FDAJul 13, 2023CA, IN• Global Vitality Inc.

Serious Brain Enhancer Capsules (Global Vitality) – E coli contamination (2023)

potential contamination with E coli

Class IIModerate

FDAJul 13, 2023CA, IN• Global Vitality Inc.

Oxacillin Injection (Sagent) – sterility issue (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Oxacillin Injection (Sagent) – sterility risk (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Fingolimod Capsules (Ascend) – dissolution failure (2023)

Failed Dissolution Specifications

Class IIModerate

FDAJul 11, 2023Nationwide• Ascend Laboratories, LLC

Oxacillin Injection (Sagent) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Hand Sanitizer (Big Machine Distillery) – Impurity Excess (2023)

CGMP Deviation: impurities exceed allowable limits.

Class IIModerate

FDAJul 10, 2023TN• Tenn South Distillery LLC dba Big Machine Distillery

Tizanidine Hydrochloride Tablet 4mg (Preferred Pharmaceuticals) – Stability Failure (2023)

Failed Stability Specifications

Class IIModerate

FDAJun 26, 2023Nationwide• Preferred Pharmaceuticals, Inc.

Diclofenac Sodium Topical Solution (Alembic) – Delivery System Defect (2023)

Defective Delivery System

Class IIModerate

FDAJun 22, 2023Nationwide• ALEMBIC PHARMACEUTICALS, INC.

Tizanidine 4mg Tablets (Dr Reddy's) – Dissolution Specification (2023)

Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

Class IIModerate

FDAJun 21, 2023Nationwide• Dr Reddy's Laboratories Limited

Original Eye Drops (K.C. Pharmaceuticals) – Manufacturing Documentation (2023)

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

Class IIModerate

FDAJun 13, 2023Nationwide• K.C. Pharmaceuticals, Inc

Dry Eye Relief Drops (K.C. Pharmaceuticals) – Manufacturing Documentation (2023)

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

Class IIModerate

FDAJun 13, 2023Nationwide• K.C. Pharmaceuticals, Inc

Nafcillin Injection 1g (Sagent) – Sterility Risk (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 19, 2023Nationwide• Sagent Pharmaceuticals Inc

Nafcillin Pharmacy Bulk Package (Sagent) – Sterility Risk (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 19, 2023Nationwide• Sagent Pharmaceuticals Inc

Nafcillin Injection 2g (Sagent) – Sterility Risk (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 19, 2023Nationwide• Sagent Pharmaceuticals Inc

Tirzepatide Solution (Revive Rx) – Sub-potent Drug (2023)

Sub-potent Drug

Class IIModerate

FDAMay 11, 2023Nationwide• Revive Rx LLC dba Revive Rx Pharmacy

HYDROmorphone HCl (SSM Health) – CGMP Program Discontinuation (2023)

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Class IIModerate

FDAMay 9, 2023IN, MO• SSM Health Care St. Louis DBA SSM St. Clare Health Center

Pin-Away Pyrental Pamoate (Denison) – Non-Food Grade Lubricant (2023)

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAMay 3, 2023Nationwide• Denison Pharmaceuticals, LLC

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