Lisinopril and hydrochlorothiazide bottle contained a foreign antiretroviral tablet
Lisinopril and Hydrochlorothiazide Tablets 20 mg/12.5 mg are being recalled after a complaint that a sealed bottle contained a foreign tablet identified as atazanavir and ritonavir. 58,968 bottles affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: a wrong drug found inside a sealed bottle means a patient could take a medicine that was never prescribed, with no injury reported in the source.
Plain-English summary
Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 100-count bottles, prescription only, manufactured for Lupin Pharmaceuticals, Inc. of Baltimore, Maryland by Lupin Limited of Nagpur, India, NDC 68180-519-01, are being recalled. The action covers 58,968 bottles.
The stated reason is a product mix up: a complaint was received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg had a foreign tablet identified as an atazanavir and ritonavir tablet 300 mg/100 mg. The FDA classified the action as Class II.
The affected lot is QA01081, expiring April 2027. Distribution was nationwide within the United States.
Patients holding the affected lot should check their tablets and speak to their pharmacist before taking any tablet that does not match the rest of the bottle. Pharmacies should follow the instructions issued by Lupin.
The recalled product
- Product
- LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
- Brand
- LISINOPRIL AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Oral tablet
- Hazard
- product-mix-up
- foreign-tablet
- wrong-drug
- class-ii
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 #: QA01081
- Exp. Date April 2027
UPCs (3)
- 0368180519010
- 0368180518013
- 0368180520016
Distribution
Distributed nationwide across the United States.
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