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Showing 221–240 of 3363 results

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Cucumber Mint Mixer (Urban River Spirits) – Unsafe Processing (2024)

Firm made non-alcoholic drink mixer in an unlicensed and uninspected facility. The product safety is concerned due to potential under-processing.

FDAJul 1, 2024AZ, CA, CO +9 more• Urban River Spirits

Lemon Drop Mixer (Urban River) – Unsafe Processing (2024)

Firm made non-alcoholic drink mixer in an unlicensed and uninspected facility. The product safety is concerned due to potential under-processing.

FDAJul 1, 2024AZ, CA, CO +9 more• Urban River Spirits

Sevelamer Carbonate Suspension (Dr. Reddy's) – Labeling Error (2024)

Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets

Class IIILow

FDAJun 26, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Hemp Bombs CBD Pain Freeze (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Asli Sesame Seeds Brown (Sands Impex) – Pesticide Excess (2024)

Product sample exceeded tolerance for pesticide Fenvalerate

FDAJun 25, 2024CO, IL, IN +5 more• Sands Impex Inc. Dba Asli Fine Foods

Hemp Bombs CBD Pain Freeze (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Nature's Script CBD Roll-On (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Hemp Bombs CBD Pain Freeze (Global Widget) – Menthol Subpotency (2024)

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

FDAJun 25, 2024Nationwide• GLOBAL WIDGET LLC

Diflorasone Diacetate Ointment (Rising Pharma) – Impurity Concerns (2024)

Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.

FDAJun 24, 2024Nationwide• Rising Pharma Holding, Inc.

SinuFrin Nasal Decongestant (Neilmed) – Sub-Potent Drug (2024)

Sub-potent Drug

FDAJun 24, 2024Nationwide• Neilmed Pharmaceuticals Inc

Dodex Injectable (Accord Healthcare) – Subpotent Drug (2024)

Subpotent drug: out of specification results

FDAJun 18, 2024Nationwide• Accord Healthcare, Inc.

Eszopiclone Tablets (Dr. Reddy's) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: Related Substances

FDAJun 4, 2024MS, OH• Dr. Reddy's Laboratories, Inc.

T-MALE Testosterone Support (NaturesPlus) – ingredient mismatch (2024)

Product is missing the ingredient TongKat Ali and has additional Rhodiola Rosea

FDAMay 31, 2024Nationwide• Natural Organics, Inc.

Homeopathic Kit (Washington Homeopathic) – Labeling Mix-up (2024)

Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.

FDAMay 31, 2024Nationwide• Washington Homeopathic Products, Inc.

Ultra T-MALE Testosterone Boost (NaturesPlus) – ingredient mismatch (2024)

Product is missing the ingredient TongKat Ali and has additional Rhodiola Rosea

FDAMay 31, 2024Nationwide• Natural Organics, Inc.

Asmanex Twisthaler (Organon) – Defective Container (2024)

Defective Container

FDAMay 28, 2024Nationwide• Organon Llc

Asmanex Twisthaler (Organon) – Defective Container (2024)

Defective Container

FDAMay 28, 2024Nationwide• Organon Llc

Asmanex Twisthaler (Organon) – Defective Container (2024)

Defective Container

FDAMay 28, 2024Nationwide• Organon Llc

Eptifibatide Injection (Eugia) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

FDAMay 22, 2024Nationwide• Eugia US LLC

Tivicay PD (GlaxoSmithKline) – Incorrect Expiration Label (2024)

Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.

FDAMay 17, 2024Nationwide• GlaxoSmithKline LLC

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