FDA Drug recall D-736-2014
PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Ga…
- FDA Drug
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Ga… by Sigma Tau Pharmaceuticals, citing 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 cau….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-736-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-01 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sigma Tau Pharmaceuticals |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot# 3012A, 3013A, 30138, Exp. 11/13 Lot# 3014A, 3014A CLIN, Exp. 12/13 |
|---|
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-736-2014%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.