🍔 Food 💊 Drugs 🏥 Medical Devices
Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. Class II

Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Pharmacy Innovations 20221222 Terminated
Distributed: Nationwide in the USA
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Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01 Class I

Reason: Presence of Particulate Matter: Glass particulate matter detected in injectable.

Pfizer Inc. 20221222 Terminated
Distributed: USA nationwide and Puerto Rico
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Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Pfizer, Madison, NJ 07940, UPC 3 0573 1769 13 5 Class I

Reason: Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Glaxosmithkline Consumer Healthcare Holdings DBA Haleon 20221206 Terminated
Distributed: Nationwide in the USA.
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Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Distributed by: Pfizer, Madison, NJ 07940, UPC 3 0573 0169 49 3 Class I

Reason: Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Glaxosmithkline Consumer Healthcare Holdings DBA Haleon 20221206 Terminated
Distributed: Nationwide in the USA.
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Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UPC 3 0573 0154 21 5), Pfizer, Madison, NJ 07940 Class I

Reason: Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Glaxosmithkline Consumer Healthcare Holdings DBA Haleon 20221206 Terminated
Distributed: Nationwide in the USA.
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Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Class I

Reason: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

Spectrum Laboratory Products, Inc. 20221219 Terminated
Distributed: Nationwide in the USA, Puerto Rico and Canada
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Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Product Code EP130 Class I

Reason: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

Spectrum Laboratory Products, Inc. 20221219 Terminated
Distributed: Nationwide in the USA, Puerto Rico and Canada
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Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3. Class II

Reason: CGMP Deviations: potential for trace amounts of product carryover.

Nephron Sc Inc 20230112 Terminated
Distributed: Nationwide in the USA
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0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3. Class II

Reason: CGMP Deviations: potential for trace amounts of product carryover.

Nephron Sc Inc 20230112 Terminated
Distributed: Nationwide in the USA
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S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9 Class II

Reason: Short Fill

Nephron Sc Inc 20230113 Terminated
Distributed: Nationwide within the United States including Puerto Rico. Guatamala
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