Cubicin — Class I drug recall D-0093-2022
Terminated recall by MERCK SHARP & DOHME CORP, reported 2021-11-10, distributed nationwide. Presence of Particulate Matter: Identified as Glass Particles
| Recall number | D-0093-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MERCK SHARP & DOHME CORP, Whitehouse Station, NJ, United States |
| Recall initiated | 2021-10-19 |
| Classified | 2021-11-03 |
| Reported by FDA | 2021-11-10 |
| Terminated | 2023-07-25 |
| Distributed | Nationwide (US) |
| Quantity | 76,163 vials |
| Reason classes | foreign material, specification failure |
| NDC | 67919-0011-01 |
| Lot numbers | 934778 |
| Expiration dates | 2022-06-20 |
Product
Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01
Reason for recall
Presence of Particulate Matter: Identified as Glass Particles
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-0093-2022. 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.