Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00.
USMycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00.
Recalling Firm: MYLAN PHARMACEUTICALS INC
Motivo del Retiro / Peligro
TranslatedPresence of precipitate
Descripción del Producto e Identificación
TranslatedMycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00.
Additional Source Details
| Field | Value |
|---|---|
| City | Morgantown |
| State | WV |
| Openfda › Unii | 9242ECW6R0 |
| Openfda › Route | INTRAVENOUS |
| Openfda › Rxcui | 311881 |
| Openfda › Spl id | 4c643876-2577-4197-ac9b-81bab65d1362 |
| Openfda › Brand name | MYCOPHENOLATE MOFETIL |
| Openfda › Spl set id | da02b428-42a4-4007-b0b7-695f2db010f2 |
| Openfda › Package ndc › 1 | 67457-386-00 |
| Openfda › Package ndc › 2 | 67457-386-81 |
| Openfda › Product ndc | 67457-386 |
| Openfda › Generic name | MYCOPHENOLATE MOFETIL |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | MYCOPHENOLATE MOFETIL |
| Openfda › Manufacturer name | Mylan Institutional LLC |
| Openfda › Application number | ANDA203859 |
| Openfda › Is original packager | true |
| Event id | 99364 |
| Address 1 | 1311 Pineview Dr |
| Address 2 | N/A |
| Code info | Lot #: 3241653, Exp 4/30/2027 |
| Postal code | 26505-3276 |
| Report date | 20260805 |
| Product type | Drugs |
| Product quantity | 5688 vials |
| Reason for recall | Presence of precipitate |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260702 |
| Initial firm notification | Letter |
| Center classification date | 20260804 |
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 Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for...?
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 ResponsableMYLAN PHARMACEUTICALS INC
- StatusOngoing
- Nivel de RiesgoClass II
- DistributionUSA Nationwide
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🚨 SAFETY ALERT: MYLAN PHARMACEUTICALS INC - Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00. Check if your household is affected: https://therecallfile.com/es/recalls/mycophenolate-mofetil-for-injection-usp-500-mg-vial-single-dose-vial-4/FDA-D-0734-2026
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