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
USOxycodone 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
Recalling Firm: Amerisource Health Services LLC
Reason for Recall / Hazard
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Product Description & Identification
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
Affected 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. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11
Additional Source Details
| Field | Value |
|---|---|
| City | Columbus |
| State | OH |
| Openfda › Unii | C1ENJ2TE6C |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 1049611 |
| Openfda › Rxcui › 2 | 1049618 |
| Openfda › Rxcui › 3 | 1049621 |
| Openfda › Rxcui › 4 | 1049683 |
| Openfda › Spl id | 4160b55c-48e1-5cb4-e063-6294a90a1d7d |
| Openfda › Brand name | OXYCODONE HYDROCHLORIDE |
| Openfda › Spl set id | aa7ac2bf-d9ed-445d-b394-4d3fe39780ca |
| Openfda › Package ndc › 1 | 68084-354-11 |
| Openfda › Package ndc › 2 | 68084-354-01 |
| Openfda › Package ndc › 3 | 68084-968-11 |
| Openfda › Package ndc › 4 | 68084-968-01 |
| Openfda › Package ndc › 5 | 68084-975-11 |
| Openfda › Package ndc › 6 | 68084-975-01 |
| Openfda › Package ndc › 7 | 68084-983-11 |
| Openfda › Package ndc › 8 | 68084-983-01 |
| Openfda › Product ndc › 1 | 68084-354 |
| Openfda › Product ndc › 2 | 68084-968 |
| Openfda › Product ndc › 3 | 68084-975 |
| Openfda › Product ndc › 4 | 68084-983 |
| Openfda › Generic name | OXYCODONE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | OXYCODONE HYDROCHLORIDE |
| Openfda › Manufacturer name | American Health Packaging |
| Openfda › Application number | ANDA091393 |
| Openfda › Original packager product ndc › 1 | 10702-018 |
| Openfda › Original packager product ndc › 2 | 10702-056 |
| Openfda › Original packager product ndc › 3 | 10702-008 |
| Openfda › Original packager product ndc › 4 | 10702-009 |
| Event id | 98308 |
| Address 1 | 2550 John Glenn Ave Ste A |
| Address 2 | N/A |
| Code info | Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027 |
| Postal code | 43217-1188 |
| Report date | 20260218 |
| Product type | Drugs |
| Product quantity | 31,676 packages |
| Reason for recall | Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260114 |
| Initial firm notification | Letter |
| Center classification date | 20260213 |
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Overview
- Recalling FirmAmerisource Health Services LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA
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🚨 SAFETY ALERT: Amerisource Health Services LLC - 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 Check if your household is affected: https://therecallfile.com/recalls/oxycodone-hydrochloride-tablets-usp-cii-5-mg-100-count-10-x-10-blister/FDA-D-0338-2026
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