Gavilyte-C Oral Solution Recalled for Failed Stability Specification
Novel Laboratories/Lupin Pharmaceuticals is recalling Gavilyte-C (polyethylene glycol-3350 and electrolytes with flavor pack) due to failed stability testing and out-of-specification osmolarity. The product is distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a stability failure and specification deviation. No illnesses, injuries, or deaths have been reported in the source text. The hazard is a manufacturing/quality control issue rather than a known pathogen or high-risk contaminant, placing it in the Moderate category.
Plain-English summary
Novel Laboratories, Inc. d.b.a. Lupin Pharmaceuticals is recalling Gavilyte-C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack due to failed stability specification and osmolarity that is out of specification. The affected product is NDC 43386-060-19, Lot S001133 with expiration date 7/2022, manufactured by Novel Laboratories, Inc. in Somerset, New Jersey. Approximately 20,814 bottles have been distributed nationwide.
Gavilyte-C is an osmotic laxative used for bowel preparation. The failed stability testing and out-of-specification osmolarity may affect the product's performance or safety profile. Consumers who have received this product should consult with their healthcare provider or pharmacist regarding whether they should continue use or obtain a replacement.
The recalled product
- Product
- GAVILYTE - C (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK)
- Brand
- GAVILYTE - C
- Manufacturer
- Novel Laboratories, Inc. d.b.a LUPIN
- Category
- Drug — Oral Solution / Laxative
- Affected units
- 20,814
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 S001133
- exp 7/2022
Distribution
Distributed nationwide across the United States.
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