Recall of 4 batches of injections caused by solution crystallization

Recently, the FDA announced two recall notices, involving 4 batches of injection products due to the crystallization of the solution; 1 batch of tablet products due to confusion in the contents of the packaging bottle.

Injection produces crystals

Recall announcement

After receiving several complaints about injection crystallization, Zydus Pharmaceutical Company in the United States voluntarily recalled four batches of acyclovir sodium injection 50 mg/mL, with two packaging specifications of 10 mL and 20 mL.

Company announcement date: March 24, 2021

FDA release date: March 25, 2021

Product Category: Medicine

Announcement reason: crystallization of injection

Recall company: Zydus Pharmaceuticals Inc.

Product description: Acyclovir sodium injection, 50 mg/mL, 10 mL and 20 mL two packaging specifications

Picture: Picture of recalled product (two packaging specifications)

Product risk

Injection of aciclovir sodium injection containing crystalline particles may be life-threatening, including inflammation and local reactions of the veins at the injection site, blood vessel damage and/or blockage, causing thrombosis (especially in the lungs); particles entering the bloodstream may cause Blood clots, leading to stroke, heart attack, decreased liver or kidney function, or tissue or cell death.

Acyclovir sodium injection is used to treat herpes simplex infection in immunocompromised patients, severe initial clinical onset of genital herpes in immunocompetent patients, herpes simplex encephalitis, neonatal herpes simplex virus infection and varicella-zoster ( Shingles) infection in immunocompromised patients.

Picture: The batch number and expiry date of the recalled product

Confusion in tablet products

Recall announcement

Alembic Pharmaceuticals voluntarily recalled a batch of 30 telmisartan tablets USP 20 mg.

Company announcement date: March 24, 2021

FDA release date: March 24, 2021

Product Category: Medicine

Reason for announcement: The product specifications on the label are inconsistent with the contents

Recall company: Alembic Pharmaceuticals (Alembic Pharmaceuticals, Inc.

Product description: Telmisartan Tablets (Telmisartan) USP, 20 mg

Picture: Two products confused (20mg on the left and 40mg on the right)

Product risk

Risk statement: Patients who take twice the dose of telmisartan for a long time may experience low blood pressure, worsening kidney function, or elevated potassium, which may be life-threatening.

Alembic Pharmaceuticals stated that it has not received any reports of adverse events related to the recall so far.

Ref.

Zydus Pharmaceuticals (USA) Inc.

Alembic Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Telmisartan Tablets, USP, 20 mg Due to Label Mix-Up.