Class II · Moderate risk
Daptomycin
CGMP Deviations
CUBICIN (daptomycin for injection)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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
Affected NDC
67919-0011-01
Compare with the code on your package — it is the most precise check available.
Drug: Daptomycin
- Recalling firm
- Cubist Pharmaceuticals, Inc.
- NDC code
- 67919-011-01
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0229-2015 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Daptomycin recalls
See all
Class II · Moderate risk
Daptomycin
CGMP Deviations
Class II · Moderate risk
Daptomycin for Injection 500 mg per vial
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Daptomycin for Injection 350 mg/vial
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Daptomycin
Lack of sterility assurance
Other recalls by Cubist Pharmaceuticals, Inc.
All 2014 recalls
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.
Class I · High risk
CUBICIN (daptomycin for injection)
Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Class I · High risk
Cubicin (daptomycin for injection)
Presence of Particulate Matter; Glass particulates observed in vials
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