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
Reason for Recall / Hazard
Presence of precipitate
Product Description & Identification
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.
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 |
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Overview
- Recalling FirmMYLAN PHARMACEUTICALS INC
- StatusOngoing
- Risk LevelClass 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/recalls/mycophenolate-mofetil-for-injection-usp-500-mg-vial-single-dose-vial-4/FDA-D-0734-2026
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