FDA Drug recall D-925-2013
Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals…
- FDA Drug
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals… by Nexus Pharmaceuticals, citing presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-925-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-01 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Nexus Pharmaceuticals |
| Distribution | US |
Product
Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, NDC 14789-300-02
Reason
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Identifiers
| code_info | a) Lot: 112911, Exp. 11/13, b) Lot: 030712, Exp. 3/14 |
|---|
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-925-2013%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.