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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
- Manufacturer
- Heritage Pharmaceuticals Inc
- Category
- Drug — Prescription Drug
- Hazard
- 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:
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