Zydus and Alembic

Zydus and Alembic initiate a recall of 2 drugs in the US

Zydus Cadila and Alembic Pharma initiate a nationwide recall of 2 drugs in the US following complaints :

The US[1] health regulator, USFDA[2], has recently posted two separate announcements on its website. These announcements state the voluntary recall of some products by two major pharma firms in the US. The two pharma firms that have initiated this action are Alembic Pharma and Zydus Cadila.

These domestic pharma firms are recalling one drug each from the US market after receiving complaints against the products. US–based arms of Zydus are recalling Acyclovir sodium vials and that of Alembic Pharma are recalling Telmisartan tablets.

Four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL, and 20 mL vials, are being voluntarily recalled by Zydus Pharmaceuticals ( USA ) Inc. The recall is being done at both hospital and user levels. This move comes into action after the company received several complaints of crystallization in the vials.

Background Story

It also added that the 50 mg/mL injection administration might lead to life–threatening adverse consequences. However, the company clarified that no reports of adverse events had been sent to the company to date, making it unrelated to the product recall.

All distributors and customers have been intimated via email and FedEx overnight courier service by Zydus. It is also arranging for the return of all Acyclovir Sodium Injection, 50 mg/mL lots. The company also requested the hospitals to stop using this product immediately. It further asked them to call the company’s recall coordinating center for returning the product.

Alembic Pharma Inc is also voluntarily recalling one lot of Telmisartan Tablets, USP[2], 20 mg from the US market. This product is packaged in 30 – count bottles to the consumer level.

This product is being recalled due to a mismatch of the bottle contents with the label in one bottle. A bottle with 30 tablets of Telmisartan tablets, 40 mg, was incorrectly labeled as 30 – count Telmisartan tablets, 20mg. This was the market complaint that led to the recall of this product.

The company claimed that the patients on a double dose of Telmisartan for a prolonged period might suffer due to this error. These patients may experience low blood pressure, worsening of kidney function, or potassium elevation due to the wrong dose. All these adverse effects may be life–threatening to the patient.

Alembic Pharma has also stated that there have been no reports of such adverse effects related to this product to date. Furthermore, it has also begun to notify its distributors and retailers through a letter regarding this recall. Arrangements are also being made to ensure the return of the recalled lot from the market.

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