Sigma-Tau Recalls Oncaspar Injection Due to Sterility Concerns
Sigma-Tau Pharmaceuticals is voluntarily recalling five lots of Oncaspar Injection because a crack under the crimp seal caused a leak, compromising sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury (such as loss of sterility in an injectable drug) are classified as Severe.
Plain-English summary
Sigma-Tau Pharmaceuticals, Inc. is conducting a voluntary recall of five lots of Oncaspar Injection (PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial). The recall is being conducted because a crack under the crimp seal caused a leak in the vials.
The affected product is identified by the following lot numbers and expiration dates: Lot# 3012A, 3013A, 30138 (Exp. 11/13) and Lot# 3014A, 3014A CLIN (Exp. 12/13). The recall covers 7,479 vials that were distributed nationwide.
The FDA has classified this recall as Class II. The primary hazard is the lack of assurance of sterility due to the physical defect in the packaging. Patients and healthcare providers should stop using the affected lots and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- 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
- Manufacturer
- Sigma-Tau Pharmaceuticals, Inc.
- Category
- Drug — Injectable
- Affected units
- 7,479
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot# 3012A
- 3013A
- 30138
- Exp. 11/13 Lot# 3014A
- 3014A CLIN
- Exp. 12/13
Distribution
Distributed nationwide across the United States.
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