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
Motivo del Retiro / Peligro
TranslatedDefective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Descripción del Producto e Identificación
TranslatedOxycodone 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
Productos Afectados
TranslatedOxycodone 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 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug pro...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Resumen
- Empresa ResponsableAmerisource Health Services LLC
- StatusOngoing
- Nivel de RiesgoClass 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/es/recalls/oxycodone-hydrochloride-tablets-usp-cii-5-mg-100-count-10-x-10-blister/FDA-D-0338-2026
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