Why it was recalled
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Product description
CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01
Lot numbers, UPCs & expiration codes
Lot #'s: CDC203, Exp 12/2015; CDC207, Exp 01/2016; CDC213, Exp 02/2016; CDC217, Exp 03/2016; CDC226, Exp 04/2016; CDC234, CDC235, Exp 05/2016; CDC243, CDC246, Exp 07/2016.
Where it was sold
Nationwide and Puerto Rico.
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-0229-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 8, 2014
- FDA report date
- Nov 5, 2014
- Quantity
- 371,879 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cubist Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0229-2015, exactly as published.
Show all FDA fields
- City
- Lexington
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 67180
- Address
- 65 Hayden Ave
- Code information
- Lot #'s: CDC203, Exp 12/2015; CDC207, Exp 01/2016; CDC213, Exp 02/2016; CDC217, Exp 03/2016; CDC226, Exp 04/2016; CDC234, CDC235, Exp 05/2016; CDC243, CDC246, Exp 07/2016.
- Postal code
- 02421-7994
- Report date
- Nov 5, 2014
- Product type
- Drugs
- Recall number
- D-0229-2015
- Classification
- Class I
- Recalling firm
- Cubist Pharmaceuticals, Inc.
- Product quantity
- 371,879 Vials
- Termination date
- Jul 29, 2016
- Reason for recall
- Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Aug 8, 2014
- Initial firm notification
- Press Release
- Center classification date
- Oct 30, 2014