Hemopropin Ointment Recalled Due to Manufacturing Process Deviations
Apipharma is voluntarily recalling Hemopropin Ointment due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects specific lot numbers distributed in Arizona.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is based on CGMP deviations with no reported illnesses or injuries stated in the source. CGMP violations represent a manufacturing process defect that warrants caution but do not constitute a high-risk pathogen or imminent serious health hazard.
Plain-English summary
Apipharma, LLC is voluntarily recalling Hemopropin Ointment (Lanolin 17.76% and Petrolatum 71.2%, Net Weight 0.7 oz / 20g tubes) due to Current Good Manufacturing Practice (CGMP) deviations. The affected product was manufactured by Apipharma d.o.o in Croatia and distributed by Apipharma, LLC in Tempe, Arizona.
The recall involves 4,218 boxes. The affected lot numbers are: A00001 (Expiration 2027-12), A00005 (Expiration 2027-01), and B00001 (Expiration 2028-02). The product is identified by UPCs 3 858882 103534 and 3 858882 101318.
Consumers who have purchased this product should stop using it. Consult a healthcare provider or pharmacist if you have questions about whether you have an affected product or if you have used it and have concerns about your health.
The recalled product
- 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
- Manufacturer
- Apipharma
- Category
- Drug — Topical / Ointment
- Hazard
- cgmp-deviation
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: A00001
- Exp.: 2027-12
- A00005
- Exp.: 2027-01
- B00001
- Exp.:2028-02
Distribution
Distributed in 1 state:
- AZ
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