🍔 Food 💊 Drugs 🏥 Medical Devices
Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3. Class I

Reason: Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.

Global Pharma Healthcare Private Limited 20230224 Ongoing
Distributed: Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.
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Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 47335-0063-86 Class III

Reason: Failed Content Uniformity Specifications

SUN PHARMACEUTICAL INDUSTRIES INC 20230309 Terminated
Distributed: USA nationwide.
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Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3 Class II

Reason: Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc 20230310 Ongoing
Distributed: US Nationwide
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Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3. Class II

Reason: Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc 20230310 Ongoing
Distributed: US Nationwide
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Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3 Class II

Reason: Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc 20230310 Ongoing
Distributed: US Nationwide
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Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3. Class II

Reason: Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc 20230310 Ongoing
Distributed: US Nationwide
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JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company Indianapolis, IN 46285 USA Class II

Reason: Labeling: Label Mix-up

Boehringer Ingelheim Pharmaceuticals, Inc. 20230309 Terminated
Distributed: Product was distributed nationwide within the United States and PR
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Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 678112000708; NDC 67172-504-01. Class II

Reason: Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.

Teva Pharmaceuticals USA Inc 20230223 Terminated
Distributed: Nationwide in the U.S.A.
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Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manufactured for: NorthStar Rx LLC., Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, c) 100 tablets per bottle, NDC 70710-1351-01, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. Class III

Reason: Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.

Zydus Pharmaceuticals (USA) Inc 20230224 Terminated
Distributed: AZ, OH, MS.
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Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7079-05 Class III

Reason: Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.

AVEVA Drug Delivery Systems, Inc. 20230215 Terminated
Distributed: Nationwide
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