Why it was recalled
Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Product description
CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
Lot numbers, UPCs & expiration codes
Lot #: 280453F, Exp 04/16
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-1382-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 17, 2014
- FDA report date
- Jun 18, 2014
- Quantity
- 51,500 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cubist Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1382-2014, exactly as published.
Show all FDA fields
- City
- Lexington
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 68025
- Address
- 65 Hayden Ave
- Code information
- Lot #: 280453F, Exp 04/16
- Postal code
- 02421-7994
- Report date
- Jun 18, 2014
- Product type
- Drugs
- Recall number
- D-1382-2014
- Classification
- Class I
- Recalling firm
- Cubist Pharmaceuticals, Inc.
- Product quantity
- 51,500 vials
- Termination date
- Jul 22, 2016
- Reason for recall
- Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Apr 17, 2014
- Initial firm notification
- Letter
- Center classification date
- Jun 12, 2014