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Recall Observatory FDA recall evidence

Drug product

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

D-0375-2025

April 09, 2025

Class II

Product summary

Firm
Apipharma
Event
Event 96601
Status
Ongoing
Classification
Class II
Quantity
4,218 boxes
Official record key
drug-enforcement:D-0375-2025

Official wording

Reason: CGMP Deviations

Code information: Lot #: A00001, Exp.: 2027-12; A00005, Exp.: 2027-01; B00001, Exp.:2028-02

Distribution pattern: AZ

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations