Why it was recalled
Presence of Particulate Matter: Identified as Glass Particles
Product description
Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01
Lot numbers, UPCs & expiration codes
Lot #: 934778, Exp. Date Jun 2022
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0093-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 19, 2021
- FDA report date
- Nov 10, 2021
- Quantity
- 76,163 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MERCK SHARP & DOHME CORP
Original FDA data
Every field from FDA enforcement report D-0093-2022, exactly as published.
Show all FDA fields
- City
- Whitehouse Station
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88867
- Address
- 1 Merck Dr
- Code information
- Lot #: 934778, Exp. Date Jun 2022
- Postal code
- 08889-3400
- Report date
- Nov 10, 2021
- Product type
- Drugs
- Recall number
- D-0093-2022
- Classification
- Class I
- Recalling firm
- MERCK SHARP & DOHME CORP
- Product quantity
- 76,163 vials
- Termination date
- Jul 25, 2023
- Reason for recall
- Presence of Particulate Matter: Identified as Glass Particles
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 19, 2021
- Initial firm notification
- Press Release
- Center classification date
- Nov 3, 2021