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Acyclovir FDA Alerts

The FDA Alerts below may be specifically about acyclovir or relate to a group or class of drugs which include acyclovir.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for acyclovir

Zydus Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection, 50 mg/mL Due to Crystallization

March 25, 2021 -- Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials.

Administration of crystalized Acyclovir Sodium Injection, 50 mg/mL has a potential of life-threatening adverse consequences including injection site inflammation of a vein and local reactions, damage and/or obstruction of blood vessels, which could induce clots, particularly in the lungs, the passage of the particulate matter into the bloodstream may lead to clots resulting in stroke, heart attack, decreased liver or kidney function or death of tissues or cells. To date, Zydus Pharmaceuticals (USA) Inc. has not received any reports of adverse events related to this product recall.

Acyclovir Sodium Injection, 50 mg/mL is indicated for the treatment of herpes simplex infections in immunocompromised patients, severe initial clinical episodes of herpes genitalis in immuno-competent patients, herpes simplex encephalitis, neonatal herpes simplex virus infection and varicella-zoster (shingles) infections in immunocompromised patients. The product is packaged in single-dose glass vials and was distributed nationwide in the USA to Cardinal Health, Amerisourcebergen Drug Corporation and Morris & Dickson Company LLC. The affected Acyclovir Sodium Injection, 50 mg/mL lots include the following lot numbers and expiration dates:

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 10x20 mL, Single-Dose Vial pack
Acyclovir Sodium Injection,
50 mg/mL, 20 mL
68382-049-10 68382-049-01 L000156 Jan 2022 10x20 mL, Single-Dose Vial pack
Acyclovir Sodium Injection
50 mg/mL, 10 mL
68382-048-10 68382-048-01 L000126 Dec 2021 10x10 mL, Single-Dose Vial pack
Acyclovir Sodium Injection
50 mg/mL, 10 mL
68382-048-10 68382-048-01 L000127 Dec 2021 10x10 mL, Single-Dose Vial pack

Zydus Pharmaceuticals (USA) Inc. has notified its distributors and customers by email and FedEx overnight courier service and is arranging for the return of all recalled Acyclovir Sodium Injection, 50 mg/mL lots. Hospitals that have the product which is being recalled should stop using it immediately and call our recall coordinating center at 1-855-671-5023 Monday – Friday (excluding holidays), 9:00 am to 5:00 pm EST.

Consumers with questions regarding this recall can contact Zydus Pharmaceuticals (USA) Inc. by phone: 1-877-993-8779 or by email: medicalaffairs@zydususa.com Monday – Friday (excluding holidays), 9:00 am to 5:00 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA


Acyclovir 400mg Tablets by Apace Packaging: Recall - Product Mix-up

ISSUE: Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister Cards may potentially also include Torsemide, 20mg Tablets.

Missing a dose of Acyclovir Tablets could cause a reactivation of a virus being treated. Unintentional dosing of Torsemide, 20mg Tablets could cause excessive urination. Serious adverse events reported in the clinical studies, for which a drug relationship could not be excluded, were atrial fibrillation, chest pain, diarrhea, digitalis intoxication, gastrointestinal hemorrhage, hyperglycemia, hyperuricemia, hypokalemia, hypotension, hypovolemia, shunt thrombosis, rash, rectal bleeding, syncope, and ventricular tachycardia.

BACKGROUND: Acyclovir Tablet, USP, 400mg 50ct Unit Dose (NDC# 50268-061-15) is used for the acute treatment of herpes zoster (shingles), for the initial treatment and management of recurrent episodes of genital herpes, and for the treatment of chickenpox. Torsemide, 20mg Tablets are used for the treatment of edema and hypertension.

The affected lot of Acyclovir 400mg Tablet is Lot 19900 with an expiration date of 05/2019. The subject product was fully distributed to R&S Northeast, and then further distributed nationwide.

RECOMMENDATION: Apace Packaging LLC has notified its distributors and customers by email and is arranging for return of all recalled product. Distributors that have any of the subject product which is being recalled should contact Customer Service at AvKARE, Inc. at 931-292-6222 to arrange for the return of the product.

Consumers with questions regarding this recall can contact Apace Packaging by 270-434-2722 Monday-Friday (8am – 4pm CST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[02/13/2018 - Press Release - Apace Packaging]


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