🍔 Food 💊 Drugs 🏥 Medical Devices
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons). Class II

Reason: Presence of Particulate Matter: Potential for glass delamination from the vials.

American Regent, Inc. 20241111 Ongoing
Distributed: Nationwide in the USA
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Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05 Class II

Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Aurobindo Pharma USA Inc 20241107 Ongoing
Distributed: USA Nationwide
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Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. Class II

Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Aurobindo Pharma USA Inc 20241107 Ongoing
Distributed: USA Nationwide
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Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. Class II

Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Aurobindo Pharma USA Inc 20241107 Ongoing
Distributed: USA Nationwide
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Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17 Class II

Reason: Subpotent drug

ACCORD HEALTHCARE, INC. 20241108 Terminated
Distributed: USA Nationwide
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Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05 Class II

Reason: cGMP Deviations

JR Watkins 20241101 Terminated
Distributed: Nationwide in the US
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LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02 Class II

Reason: CGMP violations.

Neogen Corporation 20241008 Ongoing
Distributed: Product sold directly to one distributor consignee, Bob Barker Company, an American company that sells supplies to prisons, jails, and other institutions.
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LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01 Class II

Reason: CGMP violations.

Neogen Corporation 20241008 Ongoing
Distributed: Product sold directly to one distributor consignee, Bob Barker Company, an American company that sells supplies to prisons, jails, and other institutions.
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PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6 Class II

Reason: cGMP Deviations

Unexo Life Sciences Private Limited 20241024 Terminated
Distributed: Nationwide in the US
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CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9 Class II

Reason: cGMP Deviations

Unexo Life Sciences Private Limited 20241024 Terminated
Distributed: Nationwide in the US
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