Glycopyrrolate Oral Solution Recalled for Failed Impurities and Degradation Specifications
Novadoz Pharmaceuticals is recalling Glycopyrrolate Oral Solution 1 mg/5 mL due to failed impurities and degradation specifications. Patients should contact their healthcare provider about whether to continue medication.
What this means for you
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 a Class III FDA recall with no reported illnesses or injuries. The issue is failed impurities and degradation specifications, a manufacturing quality control matter. Class III recalls are typically scored 1-2; without demonstrated patient harm, this falls into the Moderate category.
Plain-English summary
Novadoz Pharmaceuticals LLC is recalling Glycopyrrolate Oral Solution, 1 mg/5 mL, an FDA-approved prescription medication. The affected product is distributed nationwide.
The manufacturer, MSN Pharmaceuticals Inc., discovered that certain lots failed to meet FDA specifications for impurities and degradation products during quality control testing.
Patients who received prescriptions for Glycopyrrolate Oral Solution may be affected. The recall includes Lot Nos. CB2505159A and CB2505160A (expiration date 04/2027) and Lot No. CB2505161A (expiration date 05/2027).
Patients currently taking Glycopyrrolate Oral Solution should contact their pharmacist or healthcare provider to verify if they have an affected lot and discuss whether they should continue their medication. Do not stop taking this medication without consulting your healthcare provider first.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- NOVADOZ PHARMACEUTICALS LLC
- Category
- Drug — Oral Solution
- Hazard
- impurities
- 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 (5)
- Lot # CB2505159A
- CB2505160A
- Exp Date: 04/2027
- Lot # CB2505161A
- Exp Date: 05/2027
Distribution
Distributed nationwide across the United States.
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