CLASS I Drug recall · Reported 9 Jan 2013 · FDA Enforcement Report
Methylprednisolone Acetate 80 mg/mL Injection, Preserved recalled
New England Compounding Center is recalling Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in and vials, distributed nationwide in the US. The recall was initiated on 26 Sep 2012 and the FDA has classified it as Class I.
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-111-2013
- FDA event ID
- 63305
- Recalling firm
- New England Compounding Center, Framingham, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 26 Sep 2012
- FDA classified
- 31 Dec 2012
- Reported
- 9 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Sep 2012 | Recall initiated by company | |
| 31 Dec 2012 | Classified by FDA | +96 days |
| 9 Jan 2013 | 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
Non-Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Where it was distributed
Nationwide
Questions about this recall
Is Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in and vials recalled?
Yes. New England Compounding Center recalled Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in and vials on 26 Sep 2012. The recall is Class I and its status is Terminated. Recall number D-111-2013.
Why was it recalled?
Non-Sterility
Which lots are affected?
All lot codes
Where was it sold?
Nationwide
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from New England Compounding Center
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hyaluronidase 150 u/ml PF, and vials recalled | New England Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Dexamethasone Sodium Phosphate 4 mg/mL vials PF recalled | New England Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Lidocaine/Dextrose 5%/7.5% PF recalled by New England Compounding Center | New England Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Clonidine 100 mcg/mL PF and vials recalled | New England Compounding Center | Sterility | Nationwide |
| Drug | CLASS I | Methylprednisolone Acetate (PF) 80 mg/ml Injection recalled | New England Compounding Center | Sterility | Nationwide |