FDA-Drug2014-10-08Class IPACKAGING DEFECT
Cubicin daptomycin injection recalled for potential glass particulate matter
GLASSNationwide distribution
Check Cubicin injection vials for glass particles
Cubist Pharmaceuticals is recalling multiple lots of Cubicin (daptomycin for injection) 500 mg vials because some vials may contain glass particulate matter. This affects vials distributed nationwide and internationally with expiration dates between August 2014 and June 2016. No injuries have been reported.
- Check if you have any of the recalled lot numbers listed (check your vial label).
- Do not use recalled vials; contact your pharmacy or healthcare provider immediately.
- Your provider will arrange a replacement or alternative antibiotic.
Hazard
Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
Sold states
Nationwide Foreign: Israel, Taiwan
Affected count
4,966,575 Vials
Manufactured in
65 Hayden Ave, N/A, Lexington, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2015Don't want to check this manually?
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