Why it was recalled
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.
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
Lot numbers, UPCs & expiration codes
Lot# 3012A, 3013A, 30138, Exp. 11/13 Lot# 3014A, 3014A CLIN, Exp. 12/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-736-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 1, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 7479 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sigma-Tau Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-736-2014, exactly as published.
Show all FDA fields
- City
- Gaithersburg
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 66741
- Address
- 9841 Washingtonian Blvd Ste 500
- Code information
- Lot# 3012A, 3013A, 30138, Exp. 11/13 Lot# 3014A, 3014A CLIN, Exp. 12/13
- Postal code
- 20878-1978
- Report date
- Jan 22, 2014
- Product type
- Drugs
- Recall number
- D-736-2014
- Classification
- Class II
- Recalling firm
- Sigma-Tau Pharmaceuticals, Inc.
- Product quantity
- 7479 vials
- Termination date
- Dec 18, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 1, 2013
- Initial firm notification
- Telephone
- Center classification date
- Jan 15, 2014