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Showing 2281–2300 of 29086 results

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Mesalamine Delayed-Release Tablets (Sun Pharmaceutical) – Microbial Contamination (2024)

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Fexofenadine Hydrochloride Tablets 180mg (Sun Pharmaceutical) – Microbial Contamination (2024)

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Deluxe Nut Mix (Whitley's) – multiple undeclared allergens (2024)

Undeclared Allergen

Undeclared Allergen (peanuts, milk, soy, wheat, and sesame).

Class IIModerate

FDAJan 18, 2024AL, AZ, CA +25 more• Whitley Peanut Factory, Inc.

Adrenalin Epinephrine Injection (Henry Schein) – Incorrect Labeling (2024)

Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.

Class IIModerate

FDAJan 17, 2024Nationwide• Henry Schein Inc. and Glove Club HSI Gloves Inc.

Fosfomycin Tromethamine Granules (Ascend) – Impurity Specification (2024)

Failed Impurities/Degradation Specification: Out of specification for organic impurities

Class IIModerate

FDAJan 16, 2024Nationwide• Ascend Laboratories, LLC

Pan Fry Noodles (Alfred Louie) – Undeclared Wheat (2024)

Undeclared Allergen

Undeclared allergen, wheat, from not declaring sub-ingredients of enriched flour.

Class IIModerate

FDAJan 16, 2024CA• Alfred Louie Inc

Hydrogen Peroxide Oral Rinse (Den-Mat) – Specification Deviation (2024)

CGMP Deviations: products may not conform to the labeled specifications.

Class IIModerate

FDAJan 16, 2024Nationwide• Den-Mat Holdings, LLC

OralProCare Lip Treatment (Den-Mat) – Specification Deviation (2024)

CGMP Deviations: products may not conform to the labeled specifications.

Class IIModerate

FDAJan 16, 2024Nationwide• Den-Mat Holdings, LLC

Phenoxybenzamine Hydrochloride Capsules (Amneal) – Impurity Specification (2024)

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

Class IIModerate

FDAJan 15, 2024Nationwide• Amneal Pharmaceuticals of New York, LLC

Notoginseng Gout Granule (8th Ave Pharmacy) – Undeclared Drugs (2024)

Undeclared Allergen

Product contains undeclared Diclofenac and Dexamethasone Acetate

Class IIModerate

FDAJan 14, 2024AL, CO, FL +22 more• 8TH AVE PHARMACY

Budesonide Tablets (Golden State Medical) – Failed Dissolution (2024)

Failed Dissolution Specifications

Class IIModerate

FDAJan 12, 2024IL• Golden State Medical Supply Inc.

Vasopressin Sodium Chloride (IntegraDose) – Subpotent Drug (2024)

Subpotent Drug

Class IIModerate

FDAJan 12, 2024MN• IntegraDose Compounding Services LLC

Double Chocolate Croissant (Wegmans) – Undeclared Soy (2024)

Product contains undeclared soy lecithin.

Class IIModerate

FDAJan 12, 2024DE, MD, MA +6 more• Wegmans Food Markets, Inc.

Organic Trek Mix (Woodstock Farms) – Foreign Material (2024)

Product contains stem / vegetation foreign material.

Class IIModerate

FDAJan 12, 2024MD, MA, OR• United Natural Trading Inc. dba Woodstock Farms

Chocolate Croissant (Wegmans) – Undeclared Soy (2024)

Product contains undeclared soy lecithin.

Class IIModerate

FDAJan 12, 2024DE, MD, MA +6 more• Wegmans Food Markets, Inc.

Chocolate Almond Danish (Wegmans) – Undeclared Soy (2024)

Product contains undeclared soy lecithin.

Class IIModerate

FDAJan 12, 2024DE, MD, MA +6 more• Wegmans Food Markets, Inc.

Mini Danish (Wegmans) – Undeclared Soy (2024)

Product contains undeclared soy lecithin.

Class IIModerate

FDAJan 12, 2024DE, MD, MA +6 more• Wegmans Food Markets, Inc.

Chocolate Fruit & Nut Mix (Woodstock Farms) – Foreign Material (2024)

Product contains stem / vegetation foreign material.

Class IIModerate

FDAJan 12, 2024MD, MA, OR• United Natural Trading Inc. dba Woodstock Farms

Petite Pastry Tray (Wegmans) – Undeclared Soy (2024)

Product contains undeclared soy lecithin.

Class IIModerate

FDAJan 12, 2024DE, MD, MA +6 more• Wegmans Food Markets, Inc.

Vasostrict (Par Sterile Products) – Superpotent Drug (2024)

Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.

Class IIModerate

FDAJan 11, 2024Nationwide• Par Sterile Products LLC

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