FDA Drug recall D-0094-2019
Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg
- FDA Drug
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg by Heritage Pharmaceuticals, citing lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0094-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-15 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Heritage Pharmaceuticals |
| Distribution | US |
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
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Identifiers
| upc | 323155216388 |
|---|---|
| ndc | 23155-216-31 |
| ndc | 3231552163 |
| code_info | Lot #: VCIA083, Exp. JUN2020 |
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-0094-2019%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.