Ipratropium Bromide 0 — Class II drug recall D-0010-2016
Terminated recall by Nephron Pharmaceuticals Corp., reported 2015-10-21, distributed nationwide. Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
| Recall number | D-0010-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephron Pharmaceuticals Corp., Orlando, FL, United States |
| Recall initiated | 2015-08-21 |
| Classified | 2015-10-09 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2017-02-10 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 00487-0201, 00487-0201-01, 00487-0201-02, 00487-0201-03, 00487-0201-60 |
| Lot numbers | D4C21A, D4E20A |
| Expiration dates | 2016-03 |
Product
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL
Reason for recall
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
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-0010-2016. 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.