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Showing 161–180 of 216 results

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Green Bean Casserole (Robeson Enterprises) – missing ingredients (2024)

During an inspection by NCDA, the firm was notified that the label does not list the ingredients for their products.

FDAMar 26, 2024GA, NC, SC• Robeson Enterprises

Caramel Apple Pie (Robeson) – missing ingredient details (2024)

During an inspection by NCDA, the firm was notified that the label does not list the sub ingredients for their products.

FDAMar 26, 2024GA, NC, SC• Robeson Enterprises

Cherry Pie (Robeson) – missing ingredient details (2024)

During an inspection by NCDA, the firm was notified that the label does not list the sub ingredients for their products.

Class IIILow

FDAMar 26, 2024GA, NC, SC• Robeson Enterprises

Squash Casserole (Robeson) – missing ingredient list (2024)

During an inspection by NCDA, the firm was notified that the product label fails to list any ingredients.

FDAMar 26, 2024GA, NC, SC• Robeson Enterprises

Broccoli Casserole (Robeson) – missing ingredient list (2024)

During an inspection by NCDA, the firm was notified that the label does not list any ingredients in the product.

FDAMar 26, 2024GA, NC, SC• Robeson Enterprises

Clindamycin Phosphate Solution (Contract Pharmaceuticals) – container defect (2024)

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

FDAFeb 20, 2024Nationwide• Contract Pharmaceuticals Limited Canada

Clindamycin Phosphate Solution (Contract Pharmaceuticals) – container defect (2024)

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

FDAFeb 20, 2024Nationwide• Contract Pharmaceuticals Limited Canada

Mercaptopurine Tablets (Stason) – Dissolution Specification Failure (2024)

Failed Dissolution Specifications: results slightly under spec at at 9-months.

FDAFeb 9, 2024Nationwide• Stason Pharmaceuticals, Inc.

HydrALAZINE Tablets (Amerisource) – Impurities Specification (2024)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.

FDAFeb 1, 2024Nationwide• Amerisource Health Services LLC

Nortrel 7/7/7 Tablets (Teva) – Tablet Discoloration (2024)

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

FDAJan 25, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Nortrel Tablets (Teva) – Tablet Discoloration (2024)

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

FDAJan 25, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Glimepiride Tablets 1mg 500-count (Dr. Reddy's) – Tablet Misprint (2024)

Misprint on tablet

FDAJan 18, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Glimepiride Tablets 1mg (Dr. Reddy's) – Tablet Misprint (2024)

Misprint on tablet

FDAJan 18, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Benzonatate Capsules (Amerisource) – Superpotent Drug (2023)

Superpotent drug: Assay results were slightly above specification at the time zero point.

FDADec 26, 2023Nationwide• Amerisource Health Services LLC

Tropicamide/Cyclopentolate Drops (Fagron) – labeling mix-up (2023)

Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper

FDANov 10, 2023Nationwide• Fagron Compounding Services

Oxaydo Tablets (Zyla Life Sciences) – Sub-potent Drug (2023)

Sub-potent Drug: Lower potency than labeled.

FDAOct 20, 2023Nationwide• Zyla Life Sciences US Inc.

Synthroid Levothyroxine Tablets (AbbVie) – Incorrect Barcode (2023)

Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.

FDAOct 17, 2023IN, OR• AbbVie Inc.

Methotrexate Tablets (West-Ward Columbus) – surface defect (2023)

Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.

FDASep 22, 2023MS, OH• West-Ward Columbus Inc

Trandolapril/Verapamil Tablets (Glenmark) – subpotent medication (2023)

Subpotent: Out of Specification for Assay Test at the 3-month time point.

FDAAug 14, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Tobramycin Ophthalmic Solution (Alembic) – Impurity Specifications (2023)

Failed Impurities/Degradation Specifications

FDAJul 27, 2023Nationwide• ALEMBIC PHARMACEUTICALS, INC.

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