Glycopyrrolate Tabs — Class II drug recall D-0850-2020
Terminated recall by NCS Healthcare of Kentucky Inc, reported 2020-02-26, distributed nationwide. Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity
| Recall number | D-0850-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NCS Healthcare of Kentucky Inc, Glasgow, KY, United States |
| Recall initiated | 2020-01-28 |
| Classified | 2020-02-18 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2021-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 6,929 blister |
| Reason classes | specification failure |
| NDC | 00615-8170-39 |
| Lot numbers | 8170-9004 |
| Expiration dates | 2020-01 |
Product
Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39.
Reason for recall
Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
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-0850-2020. 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.