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Showing 1761–1780 of 2326 results

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Belgian Mini Cream Puffs (Poppies International) – metal contamination (2021)

The firm found small pieces of metal in the bakery palm oil silo which were not able to be detected every pass through the metal detector.

Class IIModerate

FDADec 23, 2021CA, NY, PA +1 more• Poppies International INC

Belgian Chocolate Cream Puffs (Poppies International) – metal contamination (2021)

The firm found small pieces of metal in the bakery palm oil silo which were not able to be detected every pass through the metal detector.

Class IIModerate

FDADec 23, 2021CA, NY, PA +1 more• Poppies International INC

Creme Puffs (Poppies International) – metal contamination (2021)

The firm found small pieces of metal in the bakery palm oil silo which were not able to be detected every pass through the metal detector.

Class IIModerate

FDADec 23, 2021CA, NY, PA +1 more• Poppies International INC

Medroxyprogesterone Injection (Ideal Pharmacy) – Sterility Risk (2021)

Lack of Assurance of Sterility

Class IIModerate

FDADec 21, 2021Nationwide• Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy

NaturesPlus Glucosamine (Ambix Laboratories) – Microbial Contamination (2021)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.

Class IIModerate

FDADec 6, 2021NY• Organics Corporation of America DBA Ambix Laboratories

Lidocaine Hydrochloride Solution (Teligent) - Superpotent Drug (2021)

Superpotent Drug: Minimally superpotent

Class IIModerate

FDANov 30, 2021Nationwide• Teligent Pharma, Inc.

Diclofenac Sodium Solution (Preferred) - Container Defect (2021)

Defective container: Out of specification for container integrity leading to bottles leaking.

Class IIModerate

FDANov 29, 2021CT, FL, IN +1 more• Preferred Pharmaceuticals, Inc.

Natural Dentist Mouthwash (Revive) – Labeling Error (2021)

Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8

Class IIModerate

FDASep 28, 2021Nationwide• Revive Personal Products Company

Meclizine HCl Tablets (Rising) – Incorrect Instructions (2021)

Labeling: Incorrect Instructions

Class IIModerate

FDASep 2, 2021Nationwide• RISING PHARMACEUTICALS

Chantix (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Chantix 1mg Tablets (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Chantix 0.5mg/1mg Tablets (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Chantix (Pfizer) – Impurity Risk (2021)

CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Class IIModerate

FDAAug 13, 2021Nationwide• Pfizer Inc.

Molly & Me Praline Pecans (Molly and Me) – Undeclared Soy (2021)

The firm was notified during an inspection by the State that the product contains undeclared soy.

Class IIModerate

FDAAug 4, 2021AL, AZ, AR +25 more• Molly and Me Pecans

Combipatch 0.05/0.14mg (Noven) – Stability Failure (2021)

Failed Stability Specifications; out of specification for shear.

Class IIModerate

FDAJul 30, 2021Nationwide• Noven Pharmaceuticals Inc

Combipatch 0.05/0.25mg (Noven) – Stability Failure (2021)

Failed Stability Specifications; out of specification for shear.

Class IIModerate

FDAJul 30, 2021Nationwide• Noven Pharmaceuticals Inc

Erythromycin Topical Solution (Teligent) – Container Defect (2021)

Defective container: possibility for lack of seal integrity.

Class IIModerate

FDAJul 29, 2021Nationwide• Teligent Pharma, Inc.

Miss Slim Capsules (HIS Enterprise) – Unapproved Marketing (2021)

Marketed without ANDA/NDA approval

Class IIModerate

FDAJul 20, 2021Nationwide• HIS ENTERPRISE INC

Neutrogena Beach Defense Sunscreen (Johnson & Johnson) – Manufacturing Deviation (2021)

cGMP Deviations

Class IIModerate

FDAJul 14, 2021Nationwide• Johnson & Johnson Consumer, Inc.

Neutrogena COOLDRY SPORT Micromesh Sunscreen (Johnson & Johnson) – Manufacturing Deviation (2021)

cGMP Deviations

Class IIModerate

FDAJul 14, 2021Nationwide• Johnson & Johnson Consumer, Inc.

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