FDA Drug recall D-0657-2016
Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box contain…
- FDA Drug
- Class II
- terminated
- Published 2016-02-17
On 2016-02-17 the FDA classified a Class II recall of Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box contain… by Safecor Health, citing presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0657-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-13 |
| Published | 2016-02-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Safecor Health |
| Distribution | NY |
Product
Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605.
Reason
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Identifiers
| code_info | Lot: 932333, Exp 08/04/16 |
|---|
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-0657-2016%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.