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Fentanyl and Ropivacaine Solution (Apollo Care) - Sterility Concern (2023)

Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

FDAFeb 8, 2023MO• Apollo Care

Tacrolimus Capsules (Dr. Reddy's) - Incorrect Capsule Mix (2023)

Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.

Class IIModerate

FDAFeb 8, 2023Nationwide• Dr. Reddy's Laboratories, Inc.

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Fentanyl and Ropivacaine Solution (Apollo Care) - Sterility Concern (2023)

Tacrolimus Capsules (Dr. Reddy's) - Incorrect Capsule Mix (2023)

BusPIRone Hydrochloride Tablets 15 mg (Accord Healthcare) – Manufacturing Deviation (2023)

BusPIRone Hydrochloride 10mg (Accord Healthcare) – CGMP Issues (2023)

Phenylephrine Injection (Accord) - Manufacturing Deviation (2023)

Vigabatrin Oral Solution 500 mg (Accord Healthcare) – Manufacturing Deviation (2023)

Daptomycin for Injection 500 mg (Accord Healthcare) – CGMP Deviation (2023)

Pravastatin Sodium Tablets 80 mg (Accord Healthcare) – Manufacturing Deviation (2023)

Glycopyrrolate Injection 0.2mg/mL (Accord Healthcare) – CGMP Issues (2023)

Finasteride Tablets 5 mg (Accord Healthcare) – Manufacturing Deviation (2023)

Montelukast Sodium Tablets (Accord) - Manufacturing Deviation (2023)

Dofetilide Capsules 250 mcg (Accord Healthcare) – Manufacturing Deviation (2023)

rOPINIRole Tablets 0.5 mg (Accord Healthcare) – CGMP Deviation (2023)

Pirfenidone Tablets (Accord) - Manufacturing Deviation (2023)

Pravastatin Sodium Tablets 10 mg (Accord Healthcare) – Manufacturing Deviation (2023)

Atorvastatin Calcium Tablets (Accord) - Manufacturing Deviation (2023)

Doxazosin Tablets 1mg (Accord Healthcare) – CGMP Issues (2023)

Aripiprazole Tablets (Accord) - Manufacturing Deviation (2023)

Simvastatin Tablets 80 mg (Accord Healthcare) – Manufacturing Deviation (2023)

Glimepiride Tablets 4mg (Accord Healthcare) – CGMP Issues (2023)