Cidofovir Injection 375mg/5mL — Class II drug recall D-0352-2019
Terminated recall by Heritage Pharmaceuticals, Inc., reported 2019-01-16, distributed nationwide. Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
| Recall number | D-0352-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heritage Pharmaceuticals, Inc., East Brunswick, NJ, United States |
| Recall initiated | 2019-01-02 |
| Classified | 2019-01-08 |
| Reported by FDA | 2019-01-16 |
| Terminated | 2021-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 5,060 units |
| Reason classes | sterility |
| NDC | 23155-0216-31 |
| Lot numbers | VCIA082, VCIA083, VCIA084 |
| Expiration dates | 2020-05-20, 2020-06-20 |
Product
Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31
Reason for recall
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
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-0352-2019. 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.