Class II · Moderate risk
Daptomycin
CGMP Deviations
Daptomycin
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack Of Processing Controls
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Drug: Daptomycin
- Recalling firm
- Redline Pharmacy Solutions
- Origin
- NE, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1008-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 Redline Pharmacy Solutions
All 2020 recalls
Class II · Moderate risk
Morphine Sulfate
Lack Of Processing Controls
Class II · Moderate risk
Vancomycin 900MG in 100ML 0.9% NACL Injectable
Lack Of Processing Controls
Class II · Moderate risk
Ertapenem in 100ML 0.9% NACL 1GM Injectable
Lack Of Processing Controls
Class II · Moderate risk
Morphine Sulfate
Lack Of Processing Controls
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.