FDA Drug recall D-0497-2019
Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag…
- FDA Drug
- Class III
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class III recall of Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag… by Advanced Pharma, citing superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0497-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-02-06 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Advanced Pharma |
| Distribution | US |
Product
Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.
Reason
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Identifiers
| code_info | Lot: 12/20/18 1056 73099P, BUD: 02/03/2019 |
|---|
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-0497-2019%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.