Status
Ongoing
Drug Enforcement D-0375-2025
CGMP Deviations
Classification
Class II
Report Date
April 30, 2025
Termination Date
—
Product Information
- Product description
- Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318
- Product quantity
- 4,218 boxes
- Reason for recall
- CGMP Deviations
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- AZ
Location & Firm
- Recalling firm
- Apipharma
- Address
-
Ulica Jeronima Kavanjina 26, N/A
Croatia - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0375-2025
- Event ID
- 96601
- Recall initiation date
- April 9, 2025
- Center classification date
- April 18, 2025
- Code info
- Lot #: A00001, Exp.: 2027-12; A00005, Exp.: 2027-01; B00001, Exp.:2028-02
- More code info
- —