🍔 Food 💊 Drugs 🏥 Medical Devices
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82 Class II

Reason: CGMP DEVIATIONS

Denver Solutions, LLC DBA Leiters Health 20230221 Terminated
Distributed: Nationwide within the United States including VA or other Government facilities
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Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15 Class II

Reason: CGMP DEVIATIONS

Denver Solutions, LLC DBA Leiters Health 20230221 Terminated
Distributed: Nationwide within the United States including VA or other Government facilities
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Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11 Class II

Reason: CGMP DEVIATIONS

Denver Solutions, LLC DBA Leiters Health 20230221 Terminated
Distributed: Nationwide within the United States including VA or other Government facilities
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Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60 Class II

Reason: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Teva Pharmaceuticals USA Inc 20230222 Terminated
Distributed: CA
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NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0 Class II

Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Nutraceutical Corporation 20230223 Ongoing
Distributed: Nationwide in the USA.
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NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp. NaturalCare Park City, UT, 84098 USA Class II

Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Nutraceutical Corporation 20230223 Ongoing
Distributed: Nationwide in the USA.
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NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2 Class II

Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Nutraceutical Corporation 20230223 Ongoing
Distributed: Nationwide in the USA.
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NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9 Class II

Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Nutraceutical Corporation 20230223 Ongoing
Distributed: Nationwide in the USA.
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Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11. Class II

Reason: Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.

Amerisource Health Services LLC 20230127 Terminated
Distributed: Nationwide in the USA
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Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01 Class II

Reason: Labeling: Not elsewhere classified

Sagent Pharmaceuticals Inc 20230228 Terminated
Distributed: USA Nationwide
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