Why it was recalled
Cross contamination with other products
Product description
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).
Lot numbers, UPCs & expiration codes
Lot #: L300220, Exp. 05/31/2025.
Where it was sold
Nationwide in the USA and Puerto Rico
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-0595-2024
- Classification
- Class III
- Status
- Completed
- Recall initiated
- Jul 2, 2024
- FDA report date
- Jul 17, 2024
- Quantity
- 12720 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0595-2024, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Completed
- Country
- United States
- Event ID
- 94922
- Address
- 73 Route 31 N
- Code information
- Lot #: L300220, Exp. 05/31/2025.
- Postal code
- 08534-3601
- Report date
- Jul 17, 2024
- Product type
- Drugs
- Recall number
- D-0595-2024
- Classification
- Class III
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 12720 vials
- Reason for recall
- Cross contamination with other products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Jul 2, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 10, 2024