FDA Drug Class II — Moderate

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, NDC 68084-354-01.

Hazard

Defective container: Multiple customer complaints received for card seal defects observed on the subject lots. Customers reported card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.

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Products

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. Distribute
Brand
Amerisource Health Services LLC
UPC
Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027

Units Affected

31,676 packages

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