CLASS II Drug recall · Reported 9 Jan 2013 · FDA Enforcement Report
Betamethasone Sodium Phosphate 12 mg/mL PF Injection recalled
New England Compounding Center is recalling Betamethasone Sodium Phosphate 12 mg/mL PF Injection, distributed nationwide in the US. The recall was initiated on 26 Sep 2012 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-113-2013
- FDA event ID
- 63305
- Recalling firm
- New England Compounding Center, Framingham, MA
- Classification
- Class II
- 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
Lack of Assurance of 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
Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of 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 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
16 other products · FDA event 63305This product is part of a recall event; the main page for the event is Methylprednisolone Acetate (PF) 40 mg/ml Injection recalled.
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 I | Methylprednisolone Acetate 80 mg/mL Injection, Preserved 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 |
Other Betamethasone recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Betamethasone Acetate/Betamethasone recalled | Fusion IV Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Betamethasone Acetate/Betamethasone recalled | Fusion IV Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Betamethasone Acetate/Betamethasone recalled | Fusion IV Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Betamethasone Acetate / Betamethasone Sodium Phosphate recalled | Isomeric Pharmacy Solution | Sterility | Nationwide |
| Drug | CLASS II | Betamethasone Sodium Phosphate 30 mg/ml Injectable recalled | The Compounding Pharmacy of America | Sterility | Nationwide |