Status
Terminated
Drug Enforcement D-736-2014
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.
Classification
Class II
Report Date
January 22, 2014
Termination Date
December 18, 2014
Product Information
- Product description
- 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
- Product quantity
- 7479 vials
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Sigma-Tau Pharmaceuticals, Inc.
- Address
-
9841 Washingtonian Blvd Ste 500
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-736-2014
- Event ID
- 66741
- Recall initiation date
- November 1, 2013
- Center classification date
- January 15, 2014
- Code info
- Lot# 3012A, 3013A, 30138, Exp. 11/13 Lot# 3014A, 3014A CLIN, Exp. 12/13
- More code info
- —