AuroMedics Recalls Glycopyrrolate Injection Due to Benzaldehyde Impurity
AuroMedics Pharma LLC is recalling 4,600 vials of Glycopyrrolate Injection due to elevated levels of Benzaldehyde impurity found in investigative samples.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences, and no illnesses or injuries are reported in the source text.
Plain-English summary
AuroMedics Pharma LLC is recalling 4,600 vials of Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial. The product is identified by NDC 55150-295-20, Lot #CGP190001-A, and an expiration date of 07/31/2020. The recall was initiated because elevated levels of Benzaldehyde impurity were found in investigative samples (retain samples).
The affected product was distributed in Ohio, Louisiana, and Mississippi. The medication is a prescription-only drug intended for intramuscular or intravenous use and is not for use in newborns. It contains Benzyl Alcohol and was made in India.
Healthcare providers and patients should stop using the affected product and contact AuroMedics Pharma LLC for further instructions or a replacement.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Injection
- Hazard
- Affected units
- 4,600
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 #CGP190001-A
- Exp. 07/31/2020
UPCs (1)
- 0355150295203
Distribution
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