Atropine Sulfate 0 — Class II drug recall D-0010-2017
Terminated recall by Leiter's Compounding, reported 2016-10-19, distributed nationwide. Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
| Recall number | D-0010-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leiter's Compounding, San Jose, CA, United States |
| Recall initiated | 2016-09-20 |
| Classified | 2016-10-12 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2017-05-03 |
| Distributed | Nationwide (US) |
| Quantity | 76,315 units |
| Reason classes | sterility |
| NDC | 70360-0011-39 |
Product
Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39
Reason for recall
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
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-0010-2017. 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.