Safecor Recalls Acyclovir 400mg Tablets Due to Manufacturing Deviations
Safecor Health is recalling 601 bottles of Acyclovir 400mg tablets distributed in Massachusetts and New York due to CGMP deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations, which aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls without reported injuries.
Plain-English summary
Safecor Health, LLC is voluntarily recalling 601 bottles of Acyclovir 400mg Tablets, 15-count, prescription only. The product is identified by NDC 0093894305, Lot # A25591, and an expiration date of 02/22/2017.
The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The affected product was distributed in Massachusetts and New York. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund.
The recalled product
- Product
- Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305
- Manufacturer
- Safecor Health, LLC
- Category
- Drug — Antiviral
- Hazard
- Affected units
- 601
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 # A25591
- Exp. 02/22/2017
Distribution
Part of a larger recall action
This product is one of 6 recalled by Safecor Health, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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