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Showing 501–520 of 548 results

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Muffin Tray (Bake n Show) – Foreign Objects (2021)

The firm was notified via a customer complaint that they found foreign objects in the packaging of the product.

Class IIModerate

FDAApr 19, 2021AL, AZ, CA +21 more• Genpak

Thymosin Beta-4 (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

FGL (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

Pentosan Polysulfate (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

GHK-CU (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

BPC-157 (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

CJC-1295 (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

Ipamorelin (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

LL-37 (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

B12 for Injection (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

GHRP (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

AOD-9604 (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

DSIP (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

PT-141 (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

Nandrolone (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

High Dose B12 (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

Thymosin Alpha (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

Cerebrolysin (Advanced Nutriceuticals) – Sterility Concerns (2020)

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Class IIModerate

FDANov 30, 2020CA, CO, FL +4 more• Advanced Nutriceuticals, LLC

Ranitidine Syrup (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Zantac Regular Strength (Sanofi) – NDMA impurity (2019)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class IIModerate

FDAOct 22, 2019Nationwide• Sanofi-Aventis U.S. LLC

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