Lupin Pharmaceuticals Recalls GaviLyte-C Laxative Powder Due to Failed Stability Testing
Lupin Pharmaceuticals is recalling GaviLyte-C bowel-preparation powder nationwide (26,910 bottles) because the product failed stability testing, potentially indicating degraded ingredients or reduced effectiveness. Patients should contact their doctor for a replacement.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is based on failed stability testing, which is a documented manufacturing/quality issue for a prescription medication, but the actual harm is theoretical rather than confirmed.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling GaviLyte-C (Polyethylene Glycol 3350 and electrolytes with flavor pack), an oral powder used for bowel preparation before colonoscopies and other medical procedures. The recall affects 26,910 bottles distributed nationwide, including Puerto Rico. The specific lot involved is Lot #S001132 with an expiration date of July 2022.
The recall was initiated because the product failed to meet required stability specifications. Stability testing ensures that medications maintain their proper composition, potency, and safety characteristics throughout their shelf life. When a product fails these tests, it may indicate that the active ingredients have degraded over time, potentially reducing the medication's effectiveness or creating unknown safety risks.
Patients who have received this medication should not use it and should contact their healthcare provider or pharmacy for a replacement or alternative bowel-preparation option. The FDA has classified this as a Class II recall.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- GAVILYTE - C (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK)
- Brand
- GAVILYTE - C
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Hazard
- stability-failure
- ingredient-degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # S001132
- exp. date July 2022 NDC # 43386-060-19
Distribution
Distributed nationwide across the United States.
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