Why it was recalled
Presence of Particulate Matter; Glass particulates observed in vials
Product description
Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA
Lot numbers, UPCs & expiration codes
Lot Numbers: Lot 950453F, Exp. 12/06/2013 Lot 090203F, Exp. 09/07/2014 Lot 201703F, Exp. 08/31/2015 Lot 201653F, Exp. 09/01/2015
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-764-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 29, 2013
- FDA report date
- Jan 29, 2014
- Quantity
- 179,870 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cubist Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-764-2014, exactly as published.
Show all FDA fields
- City
- Lexington
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 66041
- Address
- 65 Hayden Avenue
- Code information
- Lot Numbers: Lot 950453F, Exp. 12/06/2013 Lot 090203F, Exp. 09/07/2014 Lot 201703F, Exp. 08/31/2015 Lot 201653F, Exp. 09/01/2015
- Postal code
- 02421-7994
- Report date
- Jan 29, 2014
- Product type
- Drugs
- Recall number
- D-764-2014
- Classification
- Class I
- Recalling firm
- Cubist Pharmaceuticals, Inc.
- Product quantity
- 179,870 vials
- Termination date
- Feb 10, 2015
- Reason for recall
- Presence of Particulate Matter; Glass particulates observed in vials
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 29, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 17, 2014