Lubricant Gel Drops — Class I drug recall D-0307-2024
Ongoing recall by Kilitch Healthcare India Limited, reported 2024-02-14, distributed nationwide. Non-Sterility
| Recall number | D-0307-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kilitch Healthcare India Limited, Navi Mumbai, India |
| Recall initiated | 2023-11-13 |
| Classified | 2024-02-05 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 7,776 bottles |
| Reason classes | sterility |
| NDC | 11822-4540-03 |
Product
Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3
Reason for recall
Non-Sterility
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-0307-2024. 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.