Victus Recalls Misbranded Hipoglos Ointment Tubes in Florida
Victus, Inc. is voluntarily recalling 1,535 tubes of Hipoglos Ointment in Florida because the product is misbranded.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 due to misbranding, which aligns with the rubric criterion for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Victus, Inc. is voluntarily recalling 1,535 tubes of Hipoglos Ointment (zinc oxide and lanolin) in Florida. The product is a topical ointment used to help prevent and treat diaper rash and skin irritation. It is manufactured by Laboratorios Andromaco S.A. in Chile and distributed in various tube sizes, including 5 g, 60 g, 72 g, 100 g, and 120 g.
The recall was initiated because the product is misbranded. The recall covers specific lots with expiration dates ranging from July 31, 2013, to March 31, 2014. The recall was initiated on November 10, 2011, and was terminated on July 25, 2013.
Consumers who have purchased these specific tubes of Hipoglos Ointment should stop using the product and contact the recalling firm for instructions on how to return it. The recall is limited to the state of Florida.
The recalled product
- Product
- Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.A. Av. Quilin 5273, Penalolen, Santiago. www.hipoglos.cl, www.laboratoriosandromaco.cl, Made in Chile, Net wt. per Tube: a) 0.18 oz (5 g)…
- Manufacturer
- Victus, Inc.
- Category
- Drug — Topical Ointment
- Hazard
- Affected units
- 1,535
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 (9)
- Lot #/Product #: a) C1557B/MM26306
- Exp 03/31/2014
- b) C1387B/PV16856
- G0288C/PV16856
- Exp 07/31/2013
- c) G0288A/PV16855
- d) G0289B/PV16854
- e) C1387A/PV16853
- G0288B/PV16853
Distribution
Distributed in 1 state:
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