Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to Labeling Error
Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because an incorrect lot number appears on the case label.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a documentation/labeling discrepancy regarding the lot number on the case label.
Plain-English summary
Prinston Pharmaceutical Inc. is recalling 60 bottles (5 cases) of Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only. The product is manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd. and distributed by Solco Healthcare U.S., LLC. The recall is limited to Lot # 327B16002 with an expiration date of 12/17.
The recall was initiated due to a labeling error. The case label displays an incorrect lot number, 327B160012, while the correct lot number, 327B16002, appears on the immediate container. The FDA has classified this as a Class III recall, indicating that the violation is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot and expiration date. If found, the product should be returned to the pharmacy or distributor for credit or replacement.
The recalled product
- Product
- IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
- Brand
- IRBESARTAN AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Prinston Pharmaceutical Inc
- Category
- Drug — Prescription Drug
- Hazard
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 #: 327B16002
- Exp 12/17
UPCs (2)
- 0343547331030
- 0343547330033
Distribution
Distributed nationwide across the United States.
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