← FDA ENFORCEMENT
D-0375-2025Class II

Apipharma

Recalling firm
Apipharma
Product type
Drug
Status
Ongoing
Report date
2025-04-30
Distribution
AZ
Firm state
N/A
Product quantity
4,218 boxes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

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

Code / lot info

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

Other recalls SPEQ maps to Risk Management & CAPA
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.