Class II · Moderate risk
Daptomycin
CGMP Deviations
Daptomycin for Injection 350 mg/vial 1 Single-dose vial
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
Affected NDC
16729-0434-05
Compare with the code on your package — it is the most precise check available.
Drug: Daptomycin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Daptomycin NDC 16729-0434 |
350 mg/7mL | Injection, Powder, Lyophilized, for Solution Intravenous |
Accord Healthcare, Inc. | Rx |
- Recalling firm
- Accord Healthcare, Inc.
- NDC code
- 16729-0434-05
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0131-2023 · 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
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