🍔 Food 💊 Drugs 🏥 Medical Devices
ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68 Class II

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CARDINAL HEALTHCARE 20220126 Terminated
Distributed: Nationwide USA
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Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64 Class II

Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

CARDINAL HEALTHCARE 20220126 Terminated
Distributed: Nationwide USA
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ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869-10 Class III

Reason: Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification

GlaxoSmithKline LLC 20231212 Terminated
Distributed: Distributed Nationwide in the USA and Puerto Rico.
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Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex P.O. Box 5392, Oak Brook, IL 60522-5392. Class I

Reason: Chemical contamination: Presence of benzene

Blistex Inc 20211117 Terminated
Distributed: Nationwide with the USA, Canada and Korea
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THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL 33008 UPC 6 61799 95052 7 Class I

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

Noah's Wholesale LLC 20231016 Ongoing
Distributed: Florida, Bahamas, Turks & Caicos Islands
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NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-1, Bar code 3 51552 00411 5 Class II

Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc 20231211 Ongoing
Distributed: Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.
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NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552 00414 6 Class II

Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc 20231211 Ongoing
Distributed: Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.
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NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-3, Bar code 3 51552 00413 9 Class II

Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc 20231211 Ongoing
Distributed: Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.
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NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3 Class II

Reason: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc 20231211 Ongoing
Distributed: Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.
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Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152 Class I

Reason: Failed Content Uniformity Specifications

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 20231023 Terminated
Distributed: Nationwide in the USA
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