🍔 Food 💊 Drugs 🏥 Medical Devices
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03 Class II

Reason: Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.

Lupin Pharmaceuticals Inc. 20220913 Terminated
Distributed: Product was distributed to major distributors/wholesalers nationwide.
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Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80. Class II

Reason: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.

Direct Rx 20220912 Completed
Distributed: Physicians and Medical Facilities in GA and ID
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QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. Class II

Reason: Lack of Assurance of Sterility

Carolina Infusion 20220826 Completed
Distributed: Nationwide in the USA.
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QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. Class II

Reason: Lack of Assurance of Sterility

Carolina Infusion 20220826 Completed
Distributed: Nationwide in the USA.
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TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. Class II

Reason: Lack of Assurance of Sterility

Carolina Infusion 20220826 Completed
Distributed: Nationwide in the USA.
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TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. Class II

Reason: Lack of Assurance of Sterility

Carolina Infusion 20220826 Completed
Distributed: Nationwide in the USA.
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TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. Class II

Reason: Lack of Assurance of Sterility

Carolina Infusion 20220826 Completed
Distributed: Nationwide in the USA.
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TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. Class II

Reason: Lack of Assurance of Sterility

Carolina Infusion 20220826 Completed
Distributed: Nationwide in the USA.
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TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. Class II

Reason: Lack of Assurance of Sterility

Carolina Infusion 20220826 Completed
Distributed: Nationwide in the USA.
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TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. Class II

Reason: Lack of Assurance of Sterility

Carolina Infusion 20220826 Completed
Distributed: Nationwide in the USA.
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