Cubicin recall: Particulate Matter
CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc.…
Why was Cubicin recalled?
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc.…
- Recalling firm
- Cubist Pharmaceuticals, Inc.
- Quantity
- 371,879 Vials
- Distribution
- Nationwide and Puerto Rico.
- Recall date
- November 5, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)