🍔 Food 💊 Drugs 🏥 Medical Devices
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0110-5 Class II

Reason: Subpotent Drug

IBSA PHARMA INC 20230130 Terminated
Distributed: Nationwide in the USA.
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TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0155-5 Class II

Reason: Subpotent Drug

IBSA PHARMA INC 20230130 Terminated
Distributed: Nationwide in the USA.
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TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0140-5 Class II

Reason: Subpotent Drug

IBSA PHARMA INC 20230130 Terminated
Distributed: Nationwide in the USA.
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TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0130-5 Class II

Reason: Subpotent Drug

IBSA PHARMA INC 20230130 Terminated
Distributed: Nationwide in the USA.
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TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0105-5 Class II

Reason: Subpotent Drug

IBSA PHARMA INC 20230130 Terminated
Distributed: Nationwide in the USA.
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Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01. Class II

Reason: Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.

Dr. Reddy's Laboratories, Inc. 20230208 Ongoing
Distributed: Nationwide in the USA
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Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analgesic, NET WT. 2.75 oz (78 g), Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927, NDC# 16864-670-01 Class III

Reason: Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.

Advantice Health, Llc 20230202 Terminated
Distributed: Product was distributed via the internet, distributors and retailers nationwide.
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BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-340-01; NDC Blister Pack: 60687-340-11 Class II

Reason: Failed Impurities/Degradation Specifications

Amerisource Health Services LLC 20221227 Terminated
Distributed: Nationwide within the USA
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Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41 Class II

Reason: Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.

Leadiant Biosciences, Inc. 20230203 Terminated
Distributed: Nationwide USA
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Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. Class II

Reason: CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Consolidated Chemical, Inc 20230110 Ongoing
Distributed: Nationwide in the USA
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