CLASS II Drug recall · Reported 21 Nov 2012 · FDA Enforcement Report
All Non Sterile Products recalled by New England Compounding Center
New England Compounding Center is recalling All Non Sterile Products, distributed nationwide in the US. The recall was initiated on 6 Oct 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-053-2013
- FDA event ID
- 63511
- Recalling firm
- New England Compounding Center, Framingham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2012
- FDA classified
- 14 Nov 2012
- Reported
- 21 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Processing Deviation
- Drug class
- Compounded Drugs
Timeline
| 6 Oct 2012 | Recall initiated by company | |
| 14 Nov 2012 | Classified by FDA | +39 days |
| 21 Nov 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GMP Deviations
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
Where it was distributed
Nationwide Japan
Questions about this recall
Why was it recalled?
GMP Deviations
Which lots are affected?
All lot codes
Where was it sold?
Nationwide Japan
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
1 other product · FDA event 63511This product is part of a recall event; the main page for the event is All Sterile Products recalled by New England Compounding Center.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | All Sterile Products recalled by New England Compounding Center | New England Compounding Center | Sterility | Nationwide |
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 |