Prescription medicine recalls

KENIL HEALTHCARE PRIVATE LIMITED — Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube

CGMP Deviations

KENIL HEALTHCARE PRIVATE LIMITED — Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 557

CGMP Deviations

BRS Analytical Services, LLC — Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle

cGMP deviations and lack of assurance of sterility.

RemedyRePack Inc. — Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

Mckesson Medical-Surgical Inc. Corporate Office — PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only

CGMP Deviations; potential temperature excursions due to transit delays

Mckesson Medical-Surgical Inc. Corporate Office — EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only

CGMP Deviations; potential temperature excursions due to transit delays

Eugia US LLC — Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Mckesson Medical-Surgical Inc. Corporate Office — BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.

CGMP Deviations; potential temperature excursions due to transit delays

Eugia US LLC — Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

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.

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.

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 — 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

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..

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

cGMP deviations

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

cGMP deviations

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

cGMP deviations