🍔 Food 💊 Drugs 🏥 Medical Devices
Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10 Class III

Reason: Failed Impurities/Degradation Specifications

Caplin Steriles Limited 20230814 Terminated
Distributed: Nationwide in Tennessee
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Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03 Class III

Reason: Failed dissolution specifications: below specification results at stability 12-month

Esperion 20230816 Terminated
Distributed: Nationwide USA
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Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885 Class I

Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

APG SEVEN, INC 20230803 Ongoing
Distributed: Nationwide in the USA
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Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65 Class III

Reason: Cross contamination with other products

Lundbeck LLC 20230817 Completed
Distributed: Nationwide within the U.S.
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Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07 Class II

Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Baxter Healthcare Corporation 20230811 Terminated
Distributed: Nationwide in the USA
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DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Class II

Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Baxter Healthcare Corporation 20230811 Terminated
Distributed: Nationwide in the USA
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Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, NDC# 71428-003-60 Class III

Reason: Defective Container: slow leakage under the cap

Contract Pharmaceuticals Limited Canada 20230823 Terminated
Distributed: Nationwide in the USA.
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dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1 Class II

Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. 20230817 Terminated
Distributed: Nationwide in the USA
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dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1 Class II

Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. 20230817 Terminated
Distributed: Nationwide in the USA
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vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1 Class II

Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services, Inc. 20230817 Terminated
Distributed: Nationwide in the USA
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