Forty lifesaving drugs taken by millions are recalled over fears of 'adverse health consequences'

Importance Score: 55 / 100 🔵

FDA Issues Recall of Nearly 40 Generic Medications Due to Manufacturing Concerns

The Food and Drug Administration (FDA) has announced a recall of almost 40 generic medications, citing concerns over potential manufacturing deficiencies. These medications, produced by Glenmark Pharmaceuticals Inc. at their manufacturing facility in India, were initially subject to recall on March 13.

The FDA designated this a Class II recall on April 8, indicating a situation where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Affected Medications and Therapeutic Uses

The recalled pharmaceuticals are utilized in the treatment of a wide range of conditions, including epilepsy and diabetes, as well as multiple sclerosis, cardiovascular ailments, and hypertension. They also address renal and bladder dysfunctions, atrial fibrillation (irregular heartbeat), cerebral strokes, and epileptic seizures.

Manufacturing Standards Violation

The federal regulatory body stated that the drug production contravened Current Good Manufacturing Practice (CGMP) regulations. CGMP standards are essential guidelines that ensure pharmaceutical products are consistently produced and controlled according to quality standards.

Risk Assessment and Patient Advice

Currently, medical experts anticipate that the recalled drugs are unlikely to induce severe illness or fatalities in patients. Glenmark Pharmaceuticals has indicated on its official website that all of its tablets and capsules bear a distinctive ‘G’ imprint for easy patient identification.

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Individuals currently taking any of the 39 recalled medications are advised to seek guidance from their local pharmacist, physician, or healthcare provider to determine the appropriate next steps regarding their treatment regimen.

Examples of Recalled Medications

Among the notable medications impacted by the recall are:

• Fenofibrate capsules 67 mg: Prescribed to reduce lipid levels in the blood and manage blood pressure.
• Solifenacin Succinate 10 mg: Administered for bladder issues, including overactive bladder syndrome.
• Gabapentin tablets 600 mg: Used in the management of partial seizures, nerve pain associated with shingles, and restless legs syndrome.

Prescription and Over-the-Counter Distribution

The majority of the recalled medications are prescription-only, typically dispensed through pharmacies. However, specific batches of Glenmark Pharmaceuticals’ acetaminophen and ibuprofen tablets were also distributed through major retail outlets like Amazon and Walmart.

Certain batches of recalled cetirizine hydrochloride tablets, an antihistamine used for allergy symptom relief, were also distributed by Amazon.

As of now, neither Amazon nor Walmart have released statements concerning potential recalls of these over-the-counter tablets from their retail platforms.

Previous Recalls by Glenmark Pharmaceuticals

In June of 2024, Glenmark Pharmaceuticals also initiated a recall of 135 batches of a hypertension medication due to concerns that the capsules might not dissolve correctly after ingestion.

The company previously implemented a voluntary recall of 114 batches of 750 mg Potassium Chloride tablets, available in 100 and 500-count bottles. Specific batch numbers and expiration dates were detailed in an FDA-circulated document.

Similarly, American Health Packaging also voluntarily recalled 21 batches of the same potassium chloride medication, acting on behalf of BluePoint Laboratories.

According to a company statement, the inadequate dissolution of potassium chloride extended-release capsules carries the potential to trigger hyperkalemia, a condition characterized by elevated potassium concentrations in the bloodstream.

List of Recalled Glenmark Generic Medications

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