FDA Drug recall D-0290-2015
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg,…
- FDA Drug
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg,… by Fresenius Kabi Usa, citing defective Container: Vials may be missing stoppers.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0290-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-12 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20
Reason
Defective Container: Vials may be missing stoppers.
Identifiers
| ndc | 63323-010-01 |
|---|---|
| ndc | 63323-010-02 |
| ndc | 63323-010-03 |
| ndc | 63323-010-20 |
| code_info | Product Code: 1020; NDC: 63323-010-20; Lot Number: 6107992; Expiration Date: 09/2015 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
All Fresenius Kabi Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0290-2015%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.