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Showing 3561–3580 of 14370 results

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Chantix (Pfizer) - N-nitroso-varenicline impurity (2021)

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

Class IIModerate

FDAJun 9, 2021Nationwide• Pfizer Inc.

Chantix (Pfizer) - N-nitroso-varenicline impurity (2021)

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

Class IIModerate

FDAJun 9, 2021Nationwide• Pfizer Inc.

Xolair Injection (Genentech) – Stability Specification (2021)

Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.

Class IIModerate

FDAJun 9, 2021Nationwide• Genentech Inc

Ketamine HCl Injection (Prisma Health) - Incorrect Expiration Date (2021)

Labeling: Incorrect Exp. Date: Incorrect BUD.

FDAJun 8, 2021IN, SC• Prisma Health Outsourcing Facility

Mephyton (Bausch) - Impurity Specification Failure (2021)

Failed Impurities/Degradation Specifications

FDAJun 8, 2021Nationwide• Bausch Health Companies, Inc.

Phytonadione Tablets (Bausch) - Impurity Specification Failure (2021)

Failed Impurities/Degradation Specifications

FDAJun 8, 2021Nationwide• Bausch Health Companies, Inc.

Atorvastatin Calcium Tablets (Dr. Reddy's) - Impurity Detection (2021)

Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities

FDAJun 4, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Paximune Supplement (Bomunity) – Bacterial Contamination (2021)

Potential to be contaminated with bacteria

Class IIModerate

FDAJun 4, 2021Nationwide• Bomunity Ltd Co

Metformin Extended-Release (Viona) - NDMA Contamination (2021)

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Class IIModerate

FDAJun 1, 2021Nationwide• VIONA PHARMACEUTICALS INC

Levetiracetam Tablets (McKesson) - Barcode Error (2021)

Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam

FDAMay 26, 2021Nationwide• McKesson Corporation dba McKesson Drug Company

BTREX PLUS (Lopez Gonzalez) – Damaged Tablets (2021)

CGMP Deviations: Presence of damaged tablets

FDAMay 25, 2021PR• Lopez Gonzalez Santana Corporation

BTREX PLUS (Lopez Gonzalez) – Damaged Tablets (2021)

CGMP Deviations: Presence of damaged tablets

FDAMay 25, 2021PR• Lopez Gonzalez Santana Corporation

Solumeve Collagen Peptides (IHERB) – Undeclared Milk (2021)

Undeclared Milk

Informed by contract manufacturer that the MCT ingredient used in their product was under recall due to undeclared milk.

FDAMay 24, 2021AL, AZ, CA +29 more• IHERB LLC

DermOtic Oil (Hill Dermaceuticals) - Glass Contamination (2021)

Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.

Class IIModerate

FDAMay 21, 2021Nationwide• Hill Dermaceuticals, Inc.

Daytrana 10mg (Noven) - Patch Defect (2021)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Class IIModerate

FDAMay 20, 2021Nationwide• Noven Pharmaceuticals Inc

Daytrana 15mg (Noven) - Patch Defect (2021)

Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Class IIModerate

FDAMay 20, 2021Nationwide• Noven Pharmaceuticals Inc

PremierZEN Gold (Miracle) - Undeclared Ingredients (2021)

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

FDAMay 18, 2021Nationwide• Miracle 8989

PremierZEN Platinum (Miracle) - Undeclared Ingredients (2021)

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

FDAMay 18, 2021Nationwide• Miracle 8989

maXXzen Platinum (Miracle) - Undeclared Ingredients (2021)

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

FDAMay 18, 2021Nationwide• Miracle 8989

Mahayograj Guggulu (Garry N Sun USA) – High lead levels (2021)

State of Iowa collected consumer sample and found high levels of lead - 12,200 mg/kg

FDAMay 17, 2021AZ, AR, CA +8 more• Garry N Sun USA Inc.

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