Acyclovir Injection, Solution
FDA Recall NDC 68382-048
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Acyclovir (NDC 68382-048). A significant event, classified as Class I, was initiated on Feb 18, 2021 by Zydus Pharmaceuticals (usa) Inc.. The reported reason for this action was: "Crystallization: customer complaints for crystallization in finished product."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Crystallization: customer complaints for crystallization in finished product.
Feb 18, 2021
Apr 07, 2021
816 packs
Recall Profile & Regulatory Data
Event ID
87364
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Nov 23, 2022
Product Description
Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
Batch or Lot Expiration Information
Lot# : L000155, Exp 12/2021; L000156, Exp 1/2022
Affected Packages Involved in this Recall
68382-048-01Product
68382-048-10Product
68382-049-01Product
68382-049-10Product
Class I Terminated
Crystallization: customer complaints for crystallization in finished product.
Feb 18, 2021
Apr 07, 2021
1,638 packs
Recall Profile & Regulatory Data
Event ID
87364
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Nov 23, 2022
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.
Batch or Lot Expiration Information
Lot# : L000126, L000127, Exp 12/31/2021
Affected Packages Involved in this Recall
68382-048-01Product
68382-048-10Product
68382-049-01Product
68382-049-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
