FDA recall D-0094-2024

Product

Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11

Reason for recall

Sub-potent Drug: Lower potency than labeled.

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2023-10-20

Report date

2023-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0094-2024