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Showing 1–9 of 9 results

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Brimonidine/Timolol Ophthalmic Solution (Apotex) – sterility concern (2025)

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

FDASep 5, 2025Nationwide• Apotex Corp.

Ketorolac Tromethamine Eye Drops (Apotex) – sterility concern (2025)

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

FDASep 5, 2025Nationwide• Apotex Corp.

Ciprofloxacin Ophthalmic Solution (FDC) – Defective Container (2025)

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Class II

FDAMar 11, 2025Nationwide• FDC Limited

Lorazepam Tablets 2mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lorazepam Tablets 1mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Lorazepam Tablets 0.5mg (Major) – Potency Concern (2025)

Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.

FDAJan 21, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Ciprofloxacin Ophthalmic Solution (FDC Limited) – Defective Container (2024)

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

FDADec 16, 2024Nationwide• FDC Limited

Ciprofloxacin Ophthalmic Solution (FDC) – Defective Container (2024)

Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

FDAJul 23, 2024Nationwide• FDC Limited

Diclofenac Sodium Solution (Preferred) - Container Defect (2021)

Defective container: Out of specification for container integrity leading to bottles leaking.

FDANov 29, 2021CT, FL, IN +1 more• Preferred Pharmaceuticals, Inc.