🍔 Food 💊 Drugs 🏥 Medical Devices
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807. Class II

Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Denison Pharmaceuticals, LLC 20230503 Ongoing
Distributed: Product was distributed Nationwide.
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Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02 Class II

Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Denison Pharmaceuticals, LLC 20230503 Ongoing
Distributed: Product was distributed Nationwide.
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Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240. Class II

Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Denison Pharmaceuticals, LLC 20230503 Ongoing
Distributed: Product was distributed Nationwide.
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Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807. Class II

Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Denison Pharmaceuticals, LLC 20230503 Ongoing
Distributed: Product was distributed Nationwide.
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Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64. Class II

Reason: Sub-potent Drug

Revive Rx LLC dba Revive Rx Pharmacy 20230511 Ongoing
Distributed: Nationwide in the US
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Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28 Class III

Reason: Labeling: Incorrect or Missing Package Insert

Teva Pharmaceuticals USA Inc 20230427 Terminated
Distributed: US Nationwide
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Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28 Class III

Reason: Labeling: Incorrect or Missing Package Insert

Teva Pharmaceuticals USA Inc 20230427 Terminated
Distributed: US Nationwide
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Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28 Class III

Reason: Labeling: Incorrect or Missing Package Insert

Teva Pharmaceuticals USA Inc 20230427 Terminated
Distributed: US Nationwide
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Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28 Class III

Reason: Labeling: Incorrect or Missing Package Insert

Teva Pharmaceuticals USA Inc 20230427 Terminated
Distributed: US Nationwide
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Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28 Class III

Reason: Labeling: Incorrect or Missing Package Insert

Teva Pharmaceuticals USA Inc 20230427 Terminated
Distributed: US Nationwide
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