🍔 Food 💊 Drugs 🏥 Medical Devices
Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4. 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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Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01. 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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Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05. 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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Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02. 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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Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04. 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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Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical 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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Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15. 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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Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01. 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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Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36. 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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Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01 Class II

Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.

Hikma Pharmaceuticals USA Inc. 20220711 Terminated
Distributed: Nationwide in the USA
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