FDA Drug recall D-0574-2020
Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics P…
- FDA Drug
- Class II
- terminated
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics P… by Auromedics Pharma, citing discoloration: Product complaints of discoloration after reconstitution of vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0574-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-25 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Auromedics Pharma |
| Distribution | US |
Product
Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.
Reason
Discoloration: Product complaints of discoloration after reconstitution of vials.
Identifiers
| ndc | 55150-203-10 |
|---|---|
| ndc | 55150-204-20 |
| code_info | Lot #: CVM180003, CVM180004, Exp 04/2020; CVM180008, Exp 07/2020; CVM180009, CVM180010, CVM180011, CVM180012, Exp 09/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0574-2020%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.