FDA Drug recall D-0316-2021
Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged…
- FDA Drug
- Class I
- terminated
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class I recall of Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged… by Zydus Pharmaceuticals Usa, citing crystallization: customer complaints for crystallization in finished product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0316-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-02-18 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
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.
Reason
Crystallization: customer complaints for crystallization in finished product.
Identifiers
| ndc | 68382-048-01 |
|---|---|
| ndc | 68382-048-10 |
| ndc | 68382-049-01 |
| ndc | 68382-049-10 |
| code_info | Lot#: L000126, L000127, Exp 12/31/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0316-2021%22
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