FDA Drug recall D-0352-2019
Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mf…
- FDA Drug
- Class II
- terminated
- Published 2019-01-16
On 2019-01-16 the FDA classified a Class II recall of Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mf… by Heritage Pharmaceuticals, citing lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0352-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-02 |
| Published | 2019-01-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Heritage Pharmaceuticals |
| Distribution | US |
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
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Identifiers
| code_info | Lot #: VCIA082, Exp. MAY 2020; VCIA083, VCIA084, Exp. JUNE 2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0352-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.