Mycophenolate Mofetil for Injection — Class I drug recall D-1293-2019
Terminated recall by Par Pharmaceutical, Inc., reported 2019-05-15, distributed nationwide. Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
| Recall number | D-1293-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Par Pharmaceutical, Inc., Chestnut Ridge, NY, United States |
| Recall initiated | 2019-04-30 |
| Classified | 2019-05-22 |
| Reported by FDA | 2019-05-15 |
| Terminated | 2023-06-20 |
| Distributed | Nationwide (US) |
| Quantity | 4,506 packages |
| Reason classes | foreign material, specification failure |
| NDC | 42023-0172, 42023-0172-04 |
| Expiration dates | 2020-09 |
Product
Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044
Reason for recall
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
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-1293-2019. 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.