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Showing 201–220 of 1310 results

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Epinephrine Lidocaine HCL (Imprimis NJOF) – Sub-Potent Drug (2025)

Sub-Potent Drug: Subpotent assay results during stability testing.

Class IIModerate

FDAJul 9, 2025Nationwide• Imprimis NJOF, LLC

Rizatriptan Tablets (Ascend Laboratories) – Impurity Detection (2025)

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

Class IIModerate

FDAJul 9, 2025Nationwide• Ascend Laboratories, LLC

Timolol Maleate Ophthalmic Solution (FDC) – Defective Container (2025)

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

Class IIModerate

FDAJul 5, 2025Nationwide• FDC Limited

Amlodipine Benazepril Capsules (Lupin) – Incorrect Expiration (2025)

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

Class IIModerate

FDAJul 2, 2025Nationwide• Lupin Pharmaceuticals Inc.

Peripheral Parenteral Nutrition (CAPS) – Processing Controls (2025)

Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.

Class IIModerate

FDAJul 1, 2025CA• Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles

Omeprazole Capsules (Dr. Reddy's) – Foreign Tablets (2025)

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Class IIModerate

FDAJun 30, 2025Nationwide• Dr. Reddy's Laboratories, Inc.

Duloxetine Capsules (Breckenridge) – CGMP Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAJun 30, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Budesonide Inhalation Suspension (Cipla) – Sterility Issue (2025)

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

Class IIModerate

FDAJun 30, 2025Nationwide• Cipla USA, Inc.

Metoprolol Succinate Tablets 25mg (Granules) – Dissolution Specification Failure (2025)

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

Class IIModerate

FDAJun 24, 2025Nationwide• Granules Pharmaceuticals Inc.

Levothyroxine Sodium Tablets 175mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets 50mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets 25mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets 100mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets 150mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Lisinopril/Hydrochlorothiazide Tablets (Lupin) – Product Mix-Up (2025)

Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

Class IIModerate

FDAJun 20, 2025Nationwide• Lupin Pharmaceuticals Inc.

Levothyroxine Sodium Tablets 112mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets 25mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Gabapentin Capsules 100mg (Harvard Drug) – Defective Container (2025)

Defective container; blister packaging inadequately sealed.

Class IIModerate

FDAJun 19, 2025Nationwide• The Harvard Drug Group LLC

Gabapentin Capsules 100mg (Harvard Drug) – Defective Container (2025)

Defective container; blister packaging inadequately sealed.

Class IIModerate

FDAJun 19, 2025Nationwide• The Harvard Drug Group LLC

Lisdexamfetamine Capsules 60mg (Sun Pharma) – Dissolution Failure (2025)

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).

Class IIModerate

FDAJun 16, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

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