FDA Drug recall D-0784-2016
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd
- FDA Drug
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II recall of Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd by Dr Reddy S Laboratories, citing lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0784-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-03 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52
Reason
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
Identifiers
| ndc | 55111-688-52 |
|---|---|
| code_info | Lot BS523, exp 10/2017 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0784-2016%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.