Benztropine Mesylate Injection — Class II drug recall D-685-2013
Terminated recall by Fresenius Kabi USA, LLC, reported 2013-07-17, distributed nationwide. Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consis
| Recall number | D-685-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2013-07-01 |
| Classified | 2013-07-05 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2015-10-27 |
| Distributed | Nationwide (US) |
| Quantity | 65,110 vials |
| Reason classes | foreign material, specification failure |
| NDC | 14789-0300-02, 63323-0970, 63323-0970-02 |
| Lot numbers | 030712, 071212, 090512, 111412 |
| Expiration dates | 2014-03, 2014-07, 2014-09, 2014-11 |
Product
Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, 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 observed in reserve sample vials
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-685-2013. 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.