Zydus Pharmaceuticals Acyclovir Sodium Injection Lawsuits
WASHINGTON DC, A recall notice published on the U.S. Food and Drug Administration’s website states that Zydus Pharmaceuticals (USA) Inc has issued a national recall of its Acyclovir Sodium Injection, 50 mg/mL, 10 mL, and 20 mL vials due to crystallization. The administration of crystalized Acyclovir Sodium Injection can cause life-threatening adverse reactions and injuries such as damage and/or obstruction of blood vessels, blood clots, blood clots in the lungs, strokes, heart attacks, liver damage, kidney damage, tissue death, and fatalities. or cells. At this moment, Zydus Pharmaceuticals (USA) Inc. states that the company has not received any adverse event reports concerning this product recall.
Zydus Pharmaceuticals Inc., based in Pennington, New Jersey. is recalling four lots of Acyclovir Sodium Injection, in three vial sizes – 50 mg/mL, 10 mL, and 20 mL. The recall follows several complaints of crystallization seen inside the glass vials.
Acyclovir Sodium Injection is used in the treatment of herpes simplex infections in patients who are immunocompromised, herpes simplex encephalitis patients, severe cases of herpes genitals in immuno-competent patients, varicella-zoster (shingles) infections in immunocompromised patients, and for neonatal herpes simplex virus infection. Acyclovir Sodium Injection is packaged in single-dose glass vials and was distributed nationwide. The affected Acyclovir Sodium Injection lots have the following expiration dates and lot numbers:
| Product | Carton NDC Number | Vial NDC Number | Lot Number | Expiry Date | Pack Size |
| Acyclovir Sodium Injection, 50 mg/mL, 20 mL |
68382-049-10 | 68382-049-01 | L000155 | Dec 2021 | 10×20 mL, Single-Dose Vial pack |
| Acyclovir Sodium Injection, 50 mg/mL, 20 mL |
68382-049-10 | 68382-049-01 | L000156 | Jan 2022 | 10×20 mL, Single-Dose Vial pack |
| Acyclovir Sodium Injection 50 mg/mL, 10 mL |
68382-048-10 | 68382-048-01 | L000126 | Dec 2021 | 10×10 mL, Single-Dose Vial pack |
| Acyclovir Sodium Injection 50 mg/mL, 10 mL |
68382-048-10 | 68382-048-01 | L000127 | Dec 2021 | 10×10 mL, Single-Dose Vial pack |
According to Zydus Pharmaceuticals (USA) Inc., the company has notified its customers and distributors by email and by FedEx overnight courier service. The company is making arrangements for the return of all affected Acyclovir Sodium Injection, 50 mg/mL lots. All clinics and hospitals that have the recalled product should immediately stop using the product and the company’s recall coordinating center at zydususa.com.
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