Drug product
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11
D-0338-2026
Product summary
- Event
- Event 98308
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 31,676 packages
- Official record key
drug-enforcement:D-0338-2026
Official wording
Reason: Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Code information: Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.