KRS Global Biotechnology Recalls Hydroquinone and Tretinoin Ointment Jars
KRS Global Biotechnology is recalling 30 jars of Hydroquinone 8%/Tretinoin 0.1% Topical Ointment because the Beyond Use Date exceeds the expiration date of at least one ingredient.
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 involves a labeling error regarding the expiration date. This aligns with the rubric for moderate severity, which covers minor labeling errors and voluntary precautionary recalls without reported injuries.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 30 jars of Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment. The product is a prescription-only topical ointment packaged in jars. The recall was initiated because the Beyond Use Date (BUD) of the final product exceeds the expiration date of at least one ingredient used to make it.
The affected product is identified by Lot 08222017@37 and has a Beyond Use Date of 11/20/2017. The product was distributed nationwide in the USA, Bermuda, and New Zealand.
Consumers and healthcare providers should stop using the product and contact their pharmacist or healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Topical Ointment
- Hazard
- Affected units
- 30
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 (1)
- Lot: 08222017@37 BUD: 11/20/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 47 recalled by KRS Global Biotechnology, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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