Cidofovir injection 375 mg/mL — Class II drug recall D-0094-2019
Terminated recall by Heritage Pharmaceuticals, Inc., reported 2018-10-31, distributed nationwide. Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
| Recall number | D-0094-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heritage Pharmaceuticals, Inc., East Brunswick, NJ, United States |
| Recall initiated | 2018-10-15 |
| Classified | 2018-10-24 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2023-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 2,789 units |
| Reason classes | sterility |
| NDC | 23155-0216, 23155-0216-31 |
| Lot numbers | VCIA083 |
| Expiration dates | 2020-06-20 |
Product
Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31
Reason for recall
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the 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-0094-2019. 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.