🍔 Food 💊 Drugs 🏥 Medical Devices
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25 Class I

Reason: Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Hikma Injectables USA Inc 20240429 Completed
Distributed: CO, GA, PA, SD, WA
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Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01 Class II

Reason: Subpotent product in addition to having out-of-specification results for impurities.

American Regent, Inc. 20240513 Terminated
Distributed: USA Nationwide
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Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India. Class II

Reason: Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

SOMERSET THERAPEUTICS LLC 20240424 Ongoing
Distributed: Nationwide within the United States
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Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03 Class II

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Preferred Pharmaceuticals, Inc. 20240510 Ongoing
Distributed: Product distributed to CA, FL, OK, KS and CT
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Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01 Class III

Reason: Failed Impurities/Degradation Specifications

Dr. Reddy's Laboratories, Inc. 20240501 Ongoing
Distributed: US Nationwide.
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niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10 Class II

Reason: Lack of Assurance of Sterility.

American Regent, Inc. 20240514 Terminated
Distributed: UT only
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Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90 Class III

Reason: Failed Release Testing: Out of specification for particulate matter test.

SUN PHARMACEUTICAL INDUSTRIES INC 20240422 Ongoing
Distributed: TX, PA
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Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9 Class II

Reason: Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria

Pharma Nobis LLC 20240501 Ongoing
Distributed: USA Nationwide
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CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10. Class II

Reason: Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria

Pharma Nobis LLC 20240501 Ongoing
Distributed: USA Nationwide
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MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10 Class II

Reason: Presence of Particulate Matter: Potential for black particulates in the drug product.

Sagent Pharmaceuticals 20240425 Ongoing
Distributed: Nationwide in the USA
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