Valsartan Tablets Recalled Due to Carcinogenic Impurity
American Health Packaging is recalling Valsartan Tablets 160 mg because a carcinogenic impurity was detected in the active ingredient.
What this means for you
Illness, injury, or structural failure has been reported. 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, and the presence of a carcinogenic impurity (NDEA) in a prescription medication represents a significant health risk, aligning with the 'Severe' criteria for significant injury or high-risk contamination.
Plain-English summary
American Health Packaging is recalling Valsartan Tablets USP 160 mg, packaged in unit dose blisters. The recall involves 3,337 cartons of the medication, which was distributed nationwide in the United States and in Puerto Rico.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation. Specifically, N-Nitrosodimethylamine (NDEA), a known carcinogenic impurity, was detected in the active ingredient of the tablets. The affected product is identified by Lot 179791, with a date code of March 2020.
Consumers and healthcare providers should check their inventory for this specific lot number and stop using the product if it matches the description. Patients should consult their healthcare provider for alternative treatment options or further instructions regarding this recall.
The recalled product
- Product
- Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,337
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 179791
- Mar 2020
Distribution
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