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TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-032-15. Class II

Reason: Lack of Assurance of Sterility

AMMAN PHARMACEUTICAL INDUSTRIES 20230901 Ongoing
Distributed: Product was distributed to two (2) direct accounts in RI and CO.
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TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-027-15. Class II

Reason: Lack of Assurance of Sterility

AMMAN PHARMACEUTICAL INDUSTRIES 20230901 Ongoing
Distributed: Product was distributed to two (2) direct accounts in RI and CO.
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WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5 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.

Hua Da Trading, Inc. dba Wefun Inc. 20230825 Terminated
Distributed: Distributed Nationwide in the USA
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Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16 Class II

Reason: Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

VistaPharm LLC 20230830 Terminated
Distributed: Distributed nationwide to 68 consignees in the U.S.
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Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511. Class II

Reason: Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

BE PHARMACEUTICALS AG 20230905 Terminated
Distributed: Nationwide in the USA
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Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01 Class II

Reason: Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

Marlex Pharmaceuticals, Inc. 20230825 Terminated
Distributed: Nationwide in the US.
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Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01 Class I

Reason: Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

Marlex Pharmaceuticals, Inc. 20230825 Terminated
Distributed: Nationwide in the US.
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Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478 Class II

Reason: Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

AVKARE LLC 20230811 Terminated
Distributed: Affected product was distributed to nineteen (19) consignees within the united states.
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Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Manufactured for: AvKARE Pulaski, TN 38478 Class II

Reason: Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

AVKARE LLC 20230811 Terminated
Distributed: Affected product was distributed to nineteen (19) consignees within the united states.
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Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57 Class III

Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

Ascend Laboratories, LLC 20230718 Terminated
Distributed: The recall product was distributed nationwide.
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Data provided by openFDA