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Showing 3081–3100 of 29086 results

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Alpenfest Sachertote (Lidl) – Multiple Allergen Alert (2023)

Undeclared Egg

Undeclared Egg, Milk, Wheat

Class IIModerate

FDAJul 14, 2023DE, GA, IN +8 more• Lidl US TRADING

Methylphenidate Tablets (Sun Pharmaceutical) – foreign substance (2023)

Presence of Foreign Substance: Metal embedded in a tablet.

Class IIModerate

FDAJul 13, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

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

Petite Misty Mints (Plantation Candies) – Undeclared soy (2023)

Undeclared Soy

Undeclared soy

Class IIModerate

FDAJul 11, 2023IN, MA, MI +3 more• Plantation Candies, Inc.

Succinylcholine Chloride Syringe (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Tiagabine Hydrochloride Tablets (Sun Pharma) – Impurity Failure (2023)

Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

Class IIModerate

FDAJul 10, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Rocuronium Bromide Syringe (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Vancomycin IV Bag (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Phenylephrine HCl IV Bag (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

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

Norepinephrine IV Bag (SterRx) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 7, 2023Nationwide• SterRx, LLC

Sodium Bicarbonate Injection (SterRx) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 7, 2023Nationwide• SterRx, LLC

Norepinephrine IV Bag (SterRx) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 7, 2023Nationwide• SterRx, LLC

Norepinephrine IV Bag (SterRx) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 7, 2023Nationwide• SterRx, LLC

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