Recalls / Class III
Class IIID-0870-2023
Product
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
- Brand name
- Glycopyrrolate
- Generic name
- Glycopyrrolate
- Active ingredient
- Glycopyrrolate
- Route
- Intramuscular, Intravenous
- NDC
- 51662-1487
- FDA application
- ANDA090963
- Affected lot / code info
- Lot #: 2205095.1, Exp. Date 7/31/2024
Why it was recalled
Labeling: Label Mix-up
Recalling firm
- Firm
- HF Acquisition Co LLC
- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 11629 49th Pl W, Mukilteo, Washington 98275-4255
Distribution
- Quantity
- 9 boxes of 25 vials
- Distribution pattern
- Distributed in TX, AZ and CA only
Timeline
- Recall initiated
- 2023-06-06
- FDA classified
- 2023-06-08
- Posted by FDA
- 2023-06-14
- Terminated
- 2024-02-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0870-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.