🍔 Food 💊 Drugs 🏥 Medical Devices
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4 Class III

Reason: Labeling: Label Error on Declared Strength

AVKARE Inc. 20220720 Terminated
Distributed: Nationwide within the United States
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Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35. Class II

Reason: Lack of Assurance of Sterility: Complaints received of defective container closure.

CIPLA 20220802 Terminated
Distributed: Nationwide in the USA
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Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 67777-300-01 (current NDC) NDC# 67777-120-10 (discontinued) Class II

Reason: CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office 20220629 Terminated
Distributed: Nationwide in the USA.
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Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16. Class II

Reason: CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office 20220629 Terminated
Distributed: Nationwide in the USA.
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Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99. Class II

Reason: CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office 20220629 Terminated
Distributed: Nationwide in the USA.
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Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01. Class II

Reason: CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office 20220629 Terminated
Distributed: Nationwide in the USA.
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Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc. Class II

Reason: CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office 20220629 Terminated
Distributed: Nationwide in the USA.
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A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3. Class II

Reason: CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office 20220629 Terminated
Distributed: Nationwide in the USA.
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Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Sterile, 2.5 mL (0.085 FL OZ) bottle per box, Alcon, NDC 0065-8150-01. Class II

Reason: CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office 20220629 Terminated
Distributed: Nationwide in the USA.
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GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01. Class II

Reason: CGMP Deviations: products were stored outside the drug label specifications.

Mckesson Medical-Surgical Inc. Corporate Office 20220629 Terminated
Distributed: Nationwide in the USA.
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