Benztropine Mesylate Injection — Class II drug recall D-925-2013
Terminated recall by Nexus Pharmaceuticals Inc, reported 2013-09-04, distributed nationwide. Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consis
| Recall number | D-925-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nexus Pharmaceuticals Inc, Vernon Hills, IL, United States |
| Recall initiated | 2013-08-01 |
| Classified | 2013-08-27 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2016-02-08 |
| Distributed | Nationwide (US) |
| Quantity | 46,185 vials |
| Reason classes | foreign material, specification failure |
| NDC | 14789-0300-02 |
| Lot numbers | 030712, 11/13, 112911, 3/14 |
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 for recall
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-925-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.