CLASS II Drug recall · Reported 21 Mar 2018 · FDA Enforcement Report
methylPREDNISolone Sodium Succinate for Injection recalled
Sagent Pharmaceuticals is recalling methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 5 Mar 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0586-2018
- FDA event ID
- 79419
- Recalling firm
- Sagent Pharmaceuticals, Schaumburg, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2018
- FDA classified
- 12 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Mar 2018 | Recall initiated by company | |
| 12 Mar 2018 | Classified by FDA | +7 days |
| 21 Mar 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Which lots are affected?
Lot #: AJM601, Exp. Jul-2018; AJM701, AJM702, Exp. Dec-2018
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 79419| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | methylPREDNISolone Sodium Succinate for Injection recalled | Sagent Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS II | methylPREDNISolone Sodium Succinate for Injection recalled | Sagent Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Sagent Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Busulfan Injection, 60 mg per (6 mg per mL), mL Single-Dose Vials recalledBusulfan | Sagent Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 80 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS I | Docetaxel Injection, USP, 160 mg per (10 mg per mL) recalledDocetaxel | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Oxacillin for Injection, USP per pharmacy, For Intravenous Use recalled | Sagent Pharmaceuticals | Sterility | Nationwide |
Other Methylprednisolone recalls
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | methylprednisolone tablets, USP Dosepak, 4 mg recalled by GreenstoneMethylprednisolone | Greenstone | Other | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Methylprednisolone acetate Injectable Suspension recalled by Eugia USMethylprednisolone Acetate | Eugia US | Potency & Assay | 4 states |
| Drug | CLASS III | Methylprednisolone Acetate Injectable Suspension recalled | Amneal Pharmaceuticals of New York | Packaging Defects | Nationwide |
| Drug | CLASS II | Methylprednisolone 12MG IN NS Syringe, steroid recalled | Sentara Infusion Services | Sterility | Nationwide |