Acyclovir Tablets Recalled Due to Presence of Torsemide Tablets
Apace KY LLC is recalling 630 cartons of Acyclovir 400 mg tablets because some blister cavities may contain Torsemide tablets instead.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant harm or mislabeling of a different active ingredient (Torsemide vs Acyclovir) warrant a 'Severe' rating, as taking the wrong medication can lead to adverse health consequences.
Plain-English summary
Apace KY LLC is recalling 630 cartons of Acyclovir Tablets, USP, 400 mg (NDC 50268-061-11 and NDC 50268-061-15). The recall was initiated because cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities. The affected product is identified by Lot 19900 with an expiration date of 05/2019.
The product was distributed nationwide. The recall is classified as FDA Class II, indicating 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.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions. The recalling firm, Apace KY LLC, is responsible for the recall.
The recalled product
- Product
- ACYCLOVIR (ACYCLOVIR)
- Brand
- ACYCLOVIR
- Manufacturer
- Apace KY LLC
- Category
- Drug — Prescription Drug
- Affected units
- 630
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: 19900
- exp 05/2019
Distribution
Distributed nationwide across the United States.
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