Oxytocin Injection — Class II drug recall D-804-2013
Terminated recall by Fresenius Kabi USA, LLC, reported 2013-07-24, distributed nationwide. Subpotent Drug; 15-month stability test station
| Recall number | D-804-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2013-06-24 |
| Classified | 2013-07-17 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2015-04-07 |
| Distributed | Nationwide (US) |
| Quantity | 221,600 vials |
| Reason classes | potency, specification failure |
| NDC | 63323-0012-01 |
| Lot numbers | 6003648 |
| Expiration dates | 2013-06 |
Product
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.
Reason for recall
Subpotent Drug; 15-month stability test station
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-804-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.