🍔 Food 💊 Drugs 🏥 Medical Devices
Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine Distillery 1800 Abernathy Road Lynnville, TN 38472 a) 50 mL UPC 8 59105 00452 5; b) 100 mL UPC 8 59105 00453 2; c) 375 mL; d) 1/2 gallon; e) 1 gallon; f) 5 gallon; g) 55 gallon; i) Indianapolis Motor Speedway 50 mL UPC 8 59105 00452 5; j) Indianapolis Motor Speedway 375 mL UPC 8 59105 00454 9; k) Indianapolis Motor Speedway 1 gallon UPC 8 59105 00451 7; l) The Contributor 50 mL; m) Tony Kanaan Last Lap 100 mL; n) Tony Kanaan Last Lap 375 mL; o) Trexis Insurance 50 mL; p) Team Penske 50 mL; q) Middle Tennessee State University Lightning 50 mL. Class II

Reason: CGMP Deviation: impurities exceed allowable limits.

Tenn South Distillery LLC dba Big Machine Distillery 20230710 Ongoing
Distributed: TN
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Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83 Class II

Reason: Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

SUN PHARMACEUTICAL INDUSTRIES INC 20230710 Terminated
Distributed: Distributed nationwide in the USA.
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Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28 Class II

Reason: Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Teva Pharmaceuticals USA Inc 20230705 Terminated
Distributed: Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
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Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007. Class II

Reason: Failed Impurities/Degradation Specifications

L. Perrigo Company 20230209 Terminated
Distributed: Nationwide within the USA
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Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 10001. NDC 45 tablets: 80159-112-03 Class II

Reason: Failed Impurities/Degradation Specifications

L. Perrigo Company 20230209 Terminated
Distributed: Nationwide within the USA
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allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403. Class II

Reason: Failed Impurities/Degradation Specifications

L. Perrigo Company 20230209 Terminated
Distributed: Nationwide within the USA
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allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811. Class II

Reason: Failed Impurities/Degradation Specifications

L. Perrigo Company 20230209 Terminated
Distributed: Nationwide within the USA
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Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC 0113-0847-95), Distributed by: Perrigo, Allegan, MI 49010. Class II

Reason: Failed Impurities/Degradation Specifications

L. Perrigo Company 20230209 Terminated
Distributed: Nationwide within the USA
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Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78 Class II

Reason: Failed Impurities/Degradation Specifications

L. Perrigo Company 20230209 Terminated
Distributed: Nationwide within the USA
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allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons (NDC 79481-0847-1), and c) 45-count cartons (NDC 79481-0847-2), Distributed by: MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. Class II

Reason: Failed Impurities/Degradation Specifications

L. Perrigo Company 20230209 Terminated
Distributed: Nationwide within the USA
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