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Class I · Most seriousRecall completed

Acyclovir

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot#: L000155, Exp 12/2021; L000156, Exp 1/2022
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Crystallization: customer complaints for crystallization in finished product.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 foreign manufacturer
Brand nameACYCLOVIR
Generic nameACYCLOVIR
Active ingredient(s)ACYCLOVIR SODIUM
Distributed by / forZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
NDC68382-049-01
Show the full FDA record
Full product labelAcyclovir 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.
Recalling firmZydus Pharmaceuticals (USA) Inc
DistributionUSA Nationwide
Quantity816 packs
Recall initiated2021-02-18
Report date2021-04-07
Recall completed2022-11-23
Recall numberD-0315-2021
ClassificationClass I
FDA statusTerminated
Origin on filePennington NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.