Prinston Recalls Valsartan Tablets Due to Physical Specification Failures
Prinston Pharmaceutical Inc. is recalling 21,987 bottles of Valsartan 160 mg tablets because customer complaints confirmed the tablets were thicker and heavier than specifications.
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, and the hazard involves physical specification failures (thicker/heavier tablets) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Prinston Pharmaceutical Inc. is recalling 21,987 bottles of Valsartan Tablets, USP, 160 mg, 90-count bottles. The recall is due to a confirmed customer complaint that the tablets in the bottles were thicker and heavier than the required specifications.
The affected product is Valsartan (NDC 43547-369-09), manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd. and distributed by Solco Healthcare US, LLC. The specific lot number is 343B17025, with an expiration date of 03/31/19. The product was distributed nationwide in the USA and Puerto Rico.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been using this specific lot.
The recalled product
- Product
- VALSARTAN (VALSARTAN)
- Brand
- VALSARTAN
- Manufacturer
- Prinston Pharmaceutical Inc
- Category
- Drug — Prescription Drug
- Affected units
- 21,987
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 #: 343B17025
- Exp 03/31/19
UPCs (7)
- 0343547370039
- 0343547369033
- 0343547368098
- 0343547370091
- 0343547367039
- 0343547368036
- 0343547369095
Distribution
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