FDA Drug recall D-116-2013
Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Fr…
- FDA Drug
- Class II
- terminated
- Published 2013-01-09
On 2013-01-09 the FDA classified a Class II recall of Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Fr… by New England Compounding Center, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-116-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-26 |
| Published | 2013-01-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | New England Compounding Center |
| Distribution | US |
Product
Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | All lot codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-116-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.