products recall

Jubilant, Sun, and Lupin initiated products recall

Jubilant, Sun Pharma, and Lupin recall products from the US market citing different reasons :

The United States is the world’s largest market for medicines. Recently, three major pharma firms have initiated a voluntary products recall from the US market.

Lupin

US–based unit of Lupin has initiated a Class II recall of over 17,814 bottles of Cefprozil for Oral Suspension, USP[1]. This drug is a second–generation antibiotic used for treating ear infections, skin infections, and other bacterial infections.

Per the USFDA[2], the affected lot was being recalled as “superpotent.” These companies manufactured this lot in Lupin’s plant in Madhya Pradesh. It was distributed to the US by Baltimore – based Lupin Pharmaceuticals Inc.

On 26 March 2021, Lupin initiated the Class II voluntary recall across the US and Puerto Rico. Read more: Lupin and Aurobindo Pharma Recall certain medications

Sun Pharma

The USFDA has also revealed that Sun Pharma recalls over 13,834 bottles of diabetes drug, Riomet in the US. Riomet comprises metformin hydrochloride oral solution.

The affected lot was being recalled due to “Microbial Contamination of the Non – Sterile Product “. This lot was distributed in the US by the New Jersey–based unit of the company. [5]

This nationwide Class II recall was initiated by the company on 31 March 2021. Read about Sun Pharma launches a generic Brevipil tablet.

Jubilant Pharma

Jubilant Cadista Pharmaceuticals has also initiated a nationwide Class II recall on 1 April 2021. This drug firm is recalling around 12,192 bottles of antifungal medication, Itraconazole capsules. Jubilant initiated this action as the drug showed “Failed Dissolution Specifications. “ Company manufactured this lot in the pharma company’s Roorkee – based plant in Uttarakhand. It was marketed by the Salisbury – based unit of the company. Read about Remdesivir with NDDS: Jubilant seeks approval.

Per the FDA, Class II recall is initiated when the use of or exposure to a drug causes temporary or reversible adverse effects. It is also initiated if the probability of serious adverse effects is remote.

  According to industry estimates, the US generic drug market in 2019 is around USD[3] 115.2 billion. Read more: Pharma Products recall from the US Market

Abbreviation:

  • 1. United States Pharmacopoeia
  • 2. United States Food and Drug Administration
  • 3. United Stated Dollar

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