Prescription medicine recalls

Ascend Laboratories, LLC — Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only

Out of specification due to dissolution.

Brandywine Pharmaceuticals, LLC — Theophylline Extended-Release Tablets, 100 mg, Rx Only, 100-count bottle

CGMP Deviations: interruption in the ongoing stability testing program conducted at a third-party laboratory

Hikma Pharmaceuticals USA INC. — Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights, NJ 07922 USA by: Arab Pharmaceuticals Manufacturing PSC PO Box 41, S

Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.

Zydus Pharmaceuticals (USA) Inc — Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only

Failed Impurities/Degradation Specifications.

Greenwich Rx — Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water), 200 mg/mL, 10 mL multi-dose vial, Rx only, Subcutaneous Only, Greenwich Rx.

Microbial Contamination of Sterile Products

Viatris, Inc. — Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only

Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications

Shenzhen Techdow Pharmaceutical Co., Ltd. — Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton

Lack of Assurance of Sterility

Pfizer — Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only

Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.

Pfizer — Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only

Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.

Teva Pharmaceuticals USA, Inc — Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only

Presence of Foreign Tablets/Capsules

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.

SUN PHARMACEUTICAL INDUSTRIES INC — Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-0.

Failed Impurities/Degradation Specifications

Houston Rx LLC — Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.

Lack of assurance of sterility.

SUN PHARMACEUTICAL INDUSTRIES INC — Tretinoin Cream USP, 0.05%, 45 g tube

Failed Impurities/Degradation Specifications

Houston Rx LLC — Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.

Lack of process control

SUN PHARMACEUTICAL INDUSTRIES INC — Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.

Failed Impurities/Degradation Specifications

Apothecary Pharma LLC — Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC 85091-001-18.

Lack of Assurance of Sterility

Apothecary Pharma LLC — Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06.

Lack of Assurance of Sterility

Apotex Corp. — Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only

Failed dissolution specifications.

J&J INNOVATIVE MEDICINE — IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only

Presence of particulate matter.

ABC Compounding Co., Inc. — Lynx, LX0864 peachy-foam antiseptic handsoap, 1000 ML (33.8 FL OZ.) Manufactured by: ABC Compounding Co., INC., 2500 Dogwood Dr., Conyers, GA 30013, UPC 711808210804.

CGMP Deviations