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Impact of Subpotency in Critical Care Medications: A Closer Look at Omeprazole and Sodium Bicarbonate Recall

Bausch Health Companies Inc. has initiated a recall of 3,600 cartons of omeprazole and sodium bicarbonate powder for oral suspension due to subpotency issues identified through testing. This recall raises important considerations for the healthcare industry, particularly for physicians managing patients with conditions requiring stable and potent gastrointestinal medications. Understanding the implications of this recall is crucial for healthcare providers to ensure patient safety and effective treatment outcomes.

Key Points:

• Bausch Health Companies Inc. is recalling 3,600 cartons of omeprazole and sodium bicarbonate powder, distributed by Oceanside Pharmaceuticals, after testing revealed potential subpotency.
• The affected product is omeprazole and sodium bicarbonate powder for oral suspension, 40 mg/1680 mg, lot 0013R with an expiration date of 1/26.
• Oceanside Pharmaceuticals, a division of Bausch Health US, distributed the product across the United States, indicating a widespread impact.
• The recall was voluntarily initiated by Bausch Health Companies on February 2, 2024, with the FDA classifying it as Class II on February 28, 2024.
• A Class II recall suggests that the use of the product may lead to temporary or medically reversible adverse health consequences, with a remote possibility of serious harm.
• Omeprazole and sodium bicarbonate powder is used for treating upper gastrointestinal bleeding in critically ill adults, active duodenal ulcer, active benign gastric ulcer, and symptoms of gastroesophageal reflux disease, highlighting the critical nature of its efficacy.

According to Harvard Health Publishing, between 80% and 90% of drug recalls are Class II and in 2022, 6% of recalls were Class 1, 86% were Class II, and 7% were Class III.

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