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Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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2,003 recalls · newest first

Food & drug recall · FDASeptember 12, 2023Labelling issue

Tolmar, Inc. — Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75

Prescription medicine · Tolmar, Inc. · 2990 cartons affected

Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.

Food & drug recall · FDASeptember 8, 2023Highest risk

Church & Dwight Inc — TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6

Prescription medicine · Church & Dwight Inc · 5,316 bottles affected

Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis

Food & drug recall · FDASeptember 8, 2023Highest risk

Novartis Pharmaceuticals Corp. — SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only

Prescription medicine · Novartis Pharmaceuticals Corp. · 1272 bottles affected

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

Food & drug recall · FDASeptember 7, 2023Labelling issue

SUN PHARMACEUTICAL INDUSTRIES INC — Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only

Prescription medicine · SUN PHARMACEUTICAL INDUSTRIES INC · 69,707 cartons affected

Subpotent: Out of Specification result observed for low assay

Food & drug recall · FDASeptember 5, 2023Serious

BE PHARMACEUTICALS AG — 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 D

Prescription medicine · BE PHARMACEUTICALS AG · 41,148 vials affected

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

Food & drug recall · FDASeptember 5, 2023Labelling issue

Vi-Jon, LLC — Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle

Prescription medicine · Vi-Jon, LLC · 245,904 Bottles affected

Incorrect/Undeclared Excipients.

Food & drug recall · FDASeptember 1, 2023Labelling issue

Amerisource Health Services LLC — HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only

Prescription medicine · Amerisource Health Services LLC · 3,344 cartons affected

Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.

Food & drug recall · FDAAugust 30, 2023Serious

VistaPharm LLC — Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only

Prescription medicine · VistaPharm LLC · 14,400 bottles affected

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

Food & drug recall · FDAAugust 29, 2023Labelling issue

RB Health (US) LLC — Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in case of 6 jars per case

Prescription medicine · RB Health (US) LLC · 6,072 cases/36,426 individual selling units affected

Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.

Food & drug recall · FDAAugust 26, 2023Serious

Dr. Berne's Whole Health Products — Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle

Prescription medicine · Dr. Berne's Whole Health Products · 6060 bottles affected

CGMP Deviations

Food & drug recall · FDAAugust 26, 2023Serious

Dr. Berne's Whole Health Products — Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle

Prescription medicine · Dr. Berne's Whole Health Products · 795 bottles affected

CGMP Deviations

Food & drug recall · FDAAugust 26, 2023Highest risk

Dr. Berne's Whole Health Products — Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle

Prescription medicine · Dr. Berne's Whole Health Products · N/A affected

Non-Sterility

Food & drug recall · FDAAugust 26, 2023Serious

Dr. Berne's Whole Health Products — Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle

Prescription medicine · Dr. Berne's Whole Health Products · 3833 bottles affected

CGMP Deviations

Food & drug recall · FDAAugust 25, 2023Highest risk

Marlex Pharmaceuticals, Inc. — Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only

Prescription medicine · Marlex Pharmaceuticals, Inc. · 94/100 count bottles affected

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,…

Food & drug recall · FDAAugust 25, 2023Serious

Marlex Pharmaceuticals, Inc. — Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only

Prescription medicine · Marlex Pharmaceuticals, Inc. · 94/100 count bottles affected

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,…

Food & drug recall · FDAAugust 25, 2023Serious

CareFusion 213, LLC — BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213

Prescription medicine · CareFusion 213, LLC · 398,160 cartons affected

Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond…

Food & drug recall · FDAAugust 25, 2023Highest risk

Hua Da Trading, Inc. dba Wefun Inc. — WEFUN Capsules 825 mg, 1x10 blister pack per carton

Prescription medicine · Hua Da Trading, Inc. dba Wefun Inc. · 300 cartons affected

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product…

Food & drug recall · FDAAugust 24, 2023Serious

Baxter Healthcare Corporation — Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only

Prescription medicine · Baxter Healthcare Corporation · 472 vials affected

CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.

Food & drug recall · FDAAugust 23, 2023Labelling issue

Contract Pharmaceuticals Limited Canada — Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only

Prescription medicine · Contract Pharmaceuticals Limited Canada · 11,350 bottles affected

Defective Container: slow leakage under the cap

Food & drug recall · FDAAugust 22, 2023Serious

Sofie Co dba Sofie — Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only

Prescription medicine · Sofie Co dba Sofie · 6 patient doses affected

Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).

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