Prescription medicine recalls

American Regent, Inc. — niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Preferred Pharmaceuticals, Inc. — Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles

cGMP Deviations

FDC Limited — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

American Regent, Inc. — niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Amneal Pharmaceuticals, LLC — Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL)

Presence of Particulate Matter

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Pharmadel, LLC — DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL)

cGMP deviations

Nubratori, Inc — Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX

Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024,…

Pharmadel, LLC — Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle

cGMP deviations

Pharmadel, LLC — Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g)

cGMP deviations

Pharmadel, LLC — Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle

cGMP deviations

Pharmadel, LLC — DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL)

cGMP deviations

Pharmadel, LLC — Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL)

cGMP deviations

Apollo Care, LLC — FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO

Lack of Assurance of Sterility

OurPharma LLC — HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1040-01.

Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..

Breckenridge Pharmaceutical, Inc — Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Breckenridge Pharmaceutical, Inc — Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indiana

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Lupin Pharmaceuticals Inc. — clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation…

ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only

Subpotent

ACCORD HEALTHCARE, INC. — Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only

Subpotent