West-Ward Recalls Oxycodone Hydrochloride Oral Solution for Impurity Failures
West-Ward Columbus Inc. is recalling 1,182 bottles of Oxycodone Hydrochloride Oral Solution due to failed impurities and degradation specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
West-Ward Columbus Inc. is recalling 1,182 bottles of Oxycodone Hydrochloride Oral Solution, 5 mg/5 mL, 15 mL bottles. The product is identified by NDC 0054-0390-41, Lot #560185A, and an expiration date of 6/30/2017. The recall was initiated because the product failed impurities and degradation specifications during a 9-month stability test.
The affected product was distributed nationwide. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. The manufacturer is Boehringer Ingelheim Roxane, Inc., located in Columbus, OH.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for guidance. The recall is limited to the specific lot and expiration date listed above.
The recalled product
- Product
- OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
- Brand
- OXYCODONE HYDROCHLORIDE
- Manufacturer
- West-Ward Columbus Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,182
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 (2)
- Lot #560185A
- Exp. 6/30/2017
Distribution
Distributed nationwide across the United States.
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