Why it was recalled
Labeling: Label Mix-up
Product description
GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
Lot numbers, UPCs & expiration codes
Lot #: 2205095.1, Exp. Date 7/31/2024
Where it was sold
Distributed in TX, AZ and CA only
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0870-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 6, 2023
- FDA report date
- Jun 14, 2023
- Quantity
- 9 boxes of 25 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- HF Acquisition Co LLC
Original FDA data
Every field from FDA enforcement report D-0870-2023, exactly as published.
Show all FDA fields
- City
- Mukilteo
- State
- WA
- Status
- Terminated
- Country
- United States
- Event ID
- 92468
- Address
- 11629 49th Pl W
- Code information
- Lot #: 2205095.1, Exp. Date 7/31/2024
- Postal code
- 98275-4255
- Report date
- Jun 14, 2023
- Product type
- Drugs
- Recall number
- D-0870-2023
- Classification
- Class III
- Recalling firm
- HF Acquisition Co LLC
- Product quantity
- 9 boxes of 25 vials
- Termination date
- Feb 27, 2024
- Reason for recall
- Labeling: Label Mix-up
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3
- Distribution pattern
- Distributed in TX, AZ and CA only
- Recall initiation date
- Jun 6, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 8, 2023