🍔 Food 💊 Drugs 🏥 Medical Devices
Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562. Class II

Reason: CGMP Deviations

Alpha Aromatics 20240125 Terminated
Distributed: Product was distributed to two accounts in NC and MI
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Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60. Class II

Reason: Labeling: Incorrect or Missing Package Insert

Lupin Pharmaceuticals Inc. 20240205 Terminated
Distributed: OH, IL, NJ
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Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20 Class II

Reason: Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.

Baxter Healthcare Corporation 20240123 Ongoing
Distributed: Nationwide in the USA
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Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801. Class I

Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

Neptune Resources, LLC 20240112 Ongoing
Distributed: Nationwide in the USA
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Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801. Class I

Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

Neptune Resources, LLC 20240112 Ongoing
Distributed: Nationwide in the USA
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Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801. Class I

Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

Neptune Resources, LLC 20240112 Ongoing
Distributed: Nationwide in the USA
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Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115 Class II

Reason: CGMP Deviations: Potential Glass and Silicone particulates in product

Bestco LLC 20240119 Terminated
Distributed: Nationwide in the US
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Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115 Class II

Reason: CGMP Deviations: Potential Glass and Silicone particulates in product

Bestco LLC 20240119 Terminated
Distributed: Nationwide in the US
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Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115 Class II

Reason: CGMP Deviations: Potential Glass and Silicone particulates in product

Bestco LLC 20240119 Terminated
Distributed: Nationwide in the US
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Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115 Class II

Reason: CGMP Deviations: Potential Glass and Silicone particulates in product

Bestco LLC 20240119 Terminated
Distributed: Nationwide in the US
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