The Recall Desk
ModerateFDA (Drugs)·D-0870-2023·Announced 2023-06-14

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.

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 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
  • label-mix-up

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

Distributed in 3 states:

  • AZ
  • CA
  • TX