Systane — Class II drug recall D-1314-2022
Terminated recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2022-08-17, distributed nationwide. CGMP Deviations: products were stored outside the drug label specifications.
| Recall number | D-1314-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States |
| Recall initiated | 2022-06-29 |
| Classified | 2022-08-05 |
| Reported by FDA | 2022-08-17 |
| Terminated | 2024-02-13 |
| Distributed | Nationwide (US) |
| Quantity | 47 bottles |
| Reason classes | labeling, cgmp |
| NDC | 00065-0429, 00065-0429-15, 00065-0429-21, 00065-0429-30, 00065-0429-36, 00065-0429-67 |
Product
Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.
Reason for recall
CGMP Deviations: products were stored outside the drug label specifications.
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-1314-2022. 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.