Genus Lifesciences Recalls Oxycodone Hydrochloride Oral Solution Due to Particulate Matter
Genus Lifesciences Inc. is recalling Oxycodone Hydrochloride Oral Solution because particulate matter was found in multiple lots. The product was distributed nationwide in the USA.
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 III, which indicates a low risk of adverse health consequences. The hazard is the presence of particulate matter, which is a quality issue but not explicitly linked to severe injury or death in the source text.
Plain-English summary
Genus Lifesciences Inc. is recalling Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups. The recall was initiated because particulate matter, a foreign substance, was found in multiple lots of the product.
The affected product is a prescription-only medication distributed nationwide in the USA. The recall covers 1,171,550 cups across various lot numbers and expiration dates, including lots expiring from December 2020 through January 2022.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions. The specific lot numbers and expiration dates are listed in the official recall notice.
The recalled product
- Product
- OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
- Brand
- OXYCODONE HYDROCHLORIDE
- Manufacturer
- Genus Lifesciences Inc.
- Affected units
- 1,171,550
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 (20)
- Lot # 35400119A
- 35400219A
- 35400319A
- 35400419A
- 35400519A
- 35400619A
- EXP 12/31/20
- 35400719A
- 35400819A
- EXP 1/31/21
- 35400919A
- 35401019A
- 35401119A
- EXP 2/28/21
- 35401219A
- 35401319A
- EXP 4/30/21
- 35401419A
- 35401519A
- 35401619A
UPCs (2)
- 0364950353037
- 0364950354058
Distribution
Distributed nationwide across the United States.
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