Glycopyrrolate oral solution recalled after failing impurity and degradation specifications
Novadoz Pharmaceuticals is recalling three lots of Glycopyrrolate Oral Solution, 1 mg/5 mL, after they failed impurities and degradation specifications.
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: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites failed impurity and degradation specifications with no stated clinical consequence.
Plain-English summary
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz (473 mL), Rx only, manufactured by MSN Pharmaceuticals Inc. of Piscataway, New Jersey and distributed by Novadoz Pharmaceuticals LLC, under NDC 72205-070-72, is being recalled.
The reason given in the enforcement record is failed impurities and degradation specifications.
The record's quantity field reads 'N/A'. The recall covers lots CB2505159A and CB2505160A, expiry 04/2027, and lot CB2505161A, expiry 05/2027. Distribution was nationwide in the US. The FDA has classified the action as Class III, its least serious category.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- NOVADOZ PHARMACEUTICALS LLC
- Category
- Drug — Anticholinergic
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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