Ascent Pharmaceuticals Recalls Oxycodone Hydrochloride Tablets for Missing Label Symbol
Ascent Pharmaceuticals is recalling 45,875 bottles of Oxycodone Hydrochloride 15 mg tablets because the label is missing the required controlled substance symbol.
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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a minor labeling error (missing symbol) rather than a physical defect or contamination.
Plain-English summary
Ascent Pharmaceuticals, Inc. is recalling 45,875 bottles of Oxycodone Hydrochloride Tablets, USP 15 mg. The product is distributed nationwide and was manufactured for Camber Pharmaceuticals, Inc. The recall involves specific lot numbers with expiration dates ranging from July 2019 to November 2019.
The recall was initiated due to a labeling error where the required controlled substance CII symbol is missing from the product label. This is classified as a labeling issue not elsewhere classified.
Consumers and healthcare providers should check their inventory for the affected NDC 31722-917-01 and specific lot numbers. If found, the product should be returned to the pharmacy or distributor for proper disposal or credit, as per standard recall procedures.
The recalled product
- Product
- OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
- Brand
- OXYCODONE HYDROCHLORIDE
- Manufacturer
- Ascent Pharmaceuticals, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 45,875
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 (6)
- Lot Numbers: 17080591 and 17080619
- exp 07/19
- 17110907 and 17110908
- exp 10/19
- and 17120986
- exp 11/19
UPCs (10)
- 0331722917018
- 0331722485050
- 0331722486019
- 0331722918053
- 0331722484053
- 0331722486057
- 0331722485012
- 0331722917056
- 0331722484015
- 0331722918015
Distribution
Distributed nationwide across the United States.
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