Oxycodone Hydrochloride Oral Solution Recalled for Stability Failure
Boehringer Ingelheim Roxane Inc is recalling 2,149 vials of Oxycodone Hydrochloride Oral Solution due to out-of-specification preservative levels.
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 source text explicitly states the agency classification is Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Boehringer Ingelheim Roxane Inc is recalling 2,149 vials of OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial. The product is identified by NDC 0054-0523-41, Lot # 360241A, and an expiry date of 05/2015.
The recall was initiated because the product failed stability specifications, specifically showing an out-of-specification result for the preservative sodium benzoate. The agency 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 affected product was distributed nationwide in the United States. Consumers and healthcare providers should discontinue use of the recalled product and return it to the pharmacy or point of purchase for disposal or replacement.
The recalled product
- Product
- OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Opioid Analgesic
- Affected units
- 2,149
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 #: 360241A
- Expiry: 05/2015.
Distribution
Distributed nationwide across the United States.
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