The Recall Desk
LowFDA (Drugs)·D-0367-2021·Announced 2021-05-12

Heritage Pharmaceuticals Recalls Acyclovir Tablets Due to Labeling Errors

Heritage Pharmaceuticals is recalling 408 bottles of Acyclovir 400 mg tablets distributed in Ohio due to incorrect or missing lot and expiration dates.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is limited to documentation issues (labeling errors).

Plain-English summary

Heritage Pharmaceuticals Inc. is recalling 408 bottles of Acyclovir Tablets, USP, 400 mg. The product is distributed by Avet Pharmaceuticals Inc. and is identified by NDC 23155-227-01. The affected units are packaged in 150 cc white HDPE bottles.

The recall was initiated because the product has incorrect or missing lot and/or expiration dates. The specific lot number is A120036, with an expiration date of December 2023. The distribution pattern indicates the product was distributed in Ohio (OH).

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product
ACYCLOVIR (ACYCLOVIR)
Brand
ACYCLOVIR
Affected units
408

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot A120036
  • Exp DEC 2023

UPCs (2)

  • 0323155227017
  • 0323155228014

Distribution

Distributed in 1 state: