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Showing 6141–6160 of 15081 results

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DMPS Injection (McGuff) – Particulate Matter (2019)

Presence of Particulate Matter: Particulates observed in vials release for dispensing.

Class IIModerate

FDAFeb 14, 2019AK, AZ, CA +16 more• McGuff Compounding Pharmacy Services, Inc.

Lovastatin Tablets (Lupin) – CGMP Deviations (2019)

CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.

FDAFeb 13, 2019Nationwide• Lupin Pharmaceuticals Inc.

Maeng Da Kratom Capsules (Sunstone) – Salmonella Contamination (2019)

Salmonella

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.

Class IHigh

FDAFeb 13, 2019CA, NE, OR +1 more• Todd Holiday dba Sunstone Organics

Ciclopirox Shampoo (Perrigo) – Substance Deviation (2019)

Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.

FDAFeb 13, 2019Nationwide• Perrigo New York, Inc.

White Vein Kratom (Sunstone) – Salmonella Contamination (2019)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.

FDAFeb 13, 2019CA, NE, OR +1 more• Todd Holiday dba Sunstone Organics

Diltiazem Capsules (Mylan) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing

FDAFeb 13, 2019Nationwide• Mylan Pharmaceuticals Inc.

Labetalol Injectable (Avella) – Labeling Error (2019)

Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.

Class IIModerate

FDAFeb 8, 2019AL, AZ, CA +10 more• Avella of Deer Valley, Inc. Store 38

Magnesium Sulfate Injection (Avella) – Labeling Issue (2019)

Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.

Class IIModerate

FDAFeb 8, 2019AL, AZ, CA +10 more• Avella of Deer Valley, Inc. Store 38

Magnesium Sulfate Injection (Avella) – Labeling Problem (2019)

Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.

Class IIModerate

FDAFeb 8, 2019AL, AZ, CA +10 more• Avella of Deer Valley, Inc. Store 38

Magnesium Sulfate Injection (Avella) – Labeling Error (2019)

Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.

Class IIModerate

FDAFeb 8, 2019AL, AZ, CA +10 more• Avella of Deer Valley, Inc. Store 38

Indian Herb Paste (McDaniel) – Unapproved Drug (2019)

Unapproved new drug

Class IIModerate

FDAFeb 8, 2019Nationwide• McDaniel Life-Line LLC

Catalytic Energy Water (McDaniel) – Unapproved Drug (2019)

Unapproved new drug

Class IIModerate

FDAFeb 8, 2019Nationwide• McDaniel Life-Line LLC

Mometasone Cream (ACP) – Labeling Error (2019)

Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.

FDAFeb 7, 2019Nationwide• ACP Nimble Buyer, Inc.

Baby Gripe Water (Kingston Pharma) – undissolved ingredient (2019)

Presence of an undissolved ingredient, citrus flavonoid.

FDAFeb 7, 2019AL, AZ, AR +40 more• Kingston Pharma LLC

Gel Hand Sanitizer (Ecolab) – Benzene Contamination (2019)

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Class IIModerate

FDAFeb 6, 2019Nationwide• Ecolab Inc

Oxytocin NS 1000 mL (Advanced Pharma) – Superpotent Drug (2019)

Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

FDAFeb 6, 2019Nationwide• Advanced Pharma Inc.

Quick-Care Foam Hand Sanitizer (Ecolab) – Benzene Contamination (2019)

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Class IIModerate

FDAFeb 6, 2019Nationwide• Ecolab Inc

Advanced Gel Hand Sanitizer (Ecolab) – Benzene Contamination (2019)

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Class IIModerate

FDAFeb 6, 2019Nationwide• Ecolab Inc

Oxytocin NS 1000 mL (Advanced Pharma) – Superpotent Drug (2019)

Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

FDAFeb 6, 2019Nationwide• Advanced Pharma Inc.

Oxytocin NS 500 mL (Advanced Pharma) – Superpotent Drug (2019)

Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

FDAFeb 6, 2019Nationwide• Advanced Pharma Inc.

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