PEGASPARGASE ONCASPAR Injection — Class II drug recall D-736-2014
Terminated recall by Sigma-Tau Pharmaceuticals, Inc., reported 2014-01-22, distributed nationwide. Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of
| Recall number | D-736-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sigma-Tau Pharmaceuticals, Inc., Gaithersburg, MD, United States |
| Recall initiated | 2013-11-01 |
| Classified | 2014-01-15 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2014-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 7,479 vials |
| Reason classes | sterility, packaging |
| NDC | 54482-0301-01 |
| Lot numbers | 11/13, 3012A, 30138, 3013A, 3014A |
Product
PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01
Reason for recall
Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of Oncaspar Injection, because of a crack under the crimp seal which caused a leak.
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-736-2014. 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.