American Health Packaging Recalls Subpotent Valacyclovir HCl Tablets
American Health Packaging is recalling 1,536 cartons of Valacyclovir HCl 500 mg tablets because they contain less active ingredient than labeled.
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 source text explicitly classifies this as an FDA Class II recall. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant issues like subpotency which can lead to treatment failure.
Plain-English summary
American Health Packaging is voluntarily recalling 1,536 cartons of Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards. The recall was initiated on August 2, 2013, and the product was distributed nationwide. The specific affected lot is AHP Lot #130007 with an expiration date of 01/31/2014. The Carton NDC is 68084-633-01 and the Single Dose NDC is 68084-633-11.
The reason for the recall is that the tablets are subpotent, meaning they contain less of the active ingredient than stated on the label. This is a Class II recall, which indicates a situation where use of, or exposure to, the 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 check their inventory for the specific lot number and NDC codes listed above. If the product is found, it should be returned to the distributor or the recalling firm, American Health Packaging, located in Columbus, Ohio. The recall status is currently terminated.
The recalled product
- Product
- Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Columbus, OH NDC 68084-633-01
- Manufacturer
- American Health Packaging
- Category
- Drug — Antiviral
- Hazard
- Affected units
- 1,536
Distribution
Distributed nationwide across the United States.
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