Glycopyrrolate Injection Vials Recalled Due to Labeling Mix-up
HF Acquisition Co LLC is recalling Glycopyrrolate Injection 0.2mg/mL due to a label mix-up affecting specific lots distributed in Texas, Arizona, and California.
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: This is an FDA Class III drug recall involving a labeling error with no reported illnesses or injuries. Per the severity rubric, minor labeling errors are typically scored as Moderate (2).
Plain-English summary
HF Acquisition Co LLC is recalling Glycopyrrolate Injection, USP 0.2mg/mL in 1mL vials because of a label mix-up. The recalled product is Lot #2205095.1, which expires July 31, 2024. The recall involves 9 boxes containing 25 vials each.
The product was distributed to Texas, Arizona, and California. Healthcare facilities and patients who have this product should contact HF Acquisition Co LLC or their distributor for instructions on return and replacement.
The recalled product
- Product
- GLYCOPYRROLATE (GLYCOPYRROLATE)
- Brand
- GLYCOPYRROLATE
- Manufacturer
- HF Acquisition Co LLC
- Hazard
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 #: 2205095.1
- Exp. Date 7/31/2024
Distribution
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