Why it was recalled
Crystallization: customer complaints for crystallization in finished product.
Product description
Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
Lot numbers, UPCs & expiration codes
Lot#: L000126, L000127, Exp 12/31/2021
Where it was sold
USA Nationwide
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-0316-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 18, 2021
- FDA report date
- Apr 7, 2021
- Quantity
- 1,638 packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0316-2021, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87364
- Address
- 73 Route 31 N
- Code information
- Lot#: L000126, L000127, Exp 12/31/2021
- Postal code
- 08534-3601
- Report date
- Apr 7, 2021
- Product type
- Drugs
- Recall number
- D-0316-2021
- Classification
- Class I
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 1,638 packs
- Termination date
- Nov 23, 2022
- Reason for recall
- Crystallization: customer complaints for crystallization in finished product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Feb 18, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 30, 2021