Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31
USMethohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31
Recalling Firm: ONESOURCE SPECIALTY PHARMA LIMITED
Reason for Recall / Hazard
Failed Impurities/Degradation Specifications
Product Description & Identification
Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31
Additional Source Details
| Field | Value |
|---|---|
| City | Bengaluru |
| State | N/A |
| Openfda › Upc › 1 | 0323155893311 |
| Openfda › Upc › 2 | 0011100004492 |
| Openfda › Unii | 60200PNZ7Q |
| Openfda › Route › 1 | INTRAMUSCULAR |
| Openfda › Route › 2 | INTRAVENOUS |
| Openfda › Route › 3 | RECTAL |
| Openfda › Rxcui | 1244233 |
| Openfda › Spl id | 9ec15df7-278e-4cf3-bc97-e480b4671ca6 |
| Openfda › Brand name | METHOHEXITAL SODIUM |
| Openfda › Spl set id | f76d4ab9-2f6c-420b-afec-b9cdfdc083ce |
| Openfda › Package ndc | 23155-893-31 |
| Openfda › Product ndc | 23155-893 |
| Openfda › Generic name | METHOHEXITAL SODIUM |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | METHOHEXITAL SODIUM |
| Openfda › Manufacturer name | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. |
| Openfda › Application number | ANDA215488 |
| Openfda › Is original packager | true |
| Event id | 99220 |
| Address 1 | Plot No.: 2-D1, Obadenahalli Industrial Area, Doddaballapura |
| Address 2 | 3rd Phase; Kasa, Doddaballapura Taluk |
| Code info | Lot #: 7000612A, Exp. Date 1/2028 |
| Postal code | N/A |
| Report date | 20260715 |
| Product type | Drugs |
| Product quantity | 4284 vials |
| Reason for recall | Failed Impurities/Degradation Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260607 |
| Initial firm notification | Letter |
| Center classification date | 20260707 |
Overview
- Recalling FirmONESOURCE SPECIALTY PHARMA LIMITED
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States
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🚨 SAFETY ALERT: ONESOURCE SPECIALTY PHARMA LIMITED - Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31 Check if your household is affected: https://therecallfile.com/recalls/methohexital-sodium-for-injection-usp-500-mg-multiple-dose-vial-rx-onl/FDA-D-0662-2026
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