Lisinopril/HCTZ Tablets Recalled Due to Foreign Tablet Presence
RemedyRepack Inc. is recalling Lisinopril/HCTZ tablets because a foreign Fenofibrate tablet was found in the product bottle.
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 agency classification is FDA Class II, and the presence of a foreign medication (Fenofibrate) in a blood pressure medication poses a significant risk of unintended drug exposure and potential injury.
Plain-English summary
RemedyRepack Inc. is recalling specific blister cards of Lisinopril/HCTZ 20mg/12.5mg tablets. The recall is a spin-off of a previous action (D-1581-2019) triggered by a product complaint indicating that a Lupin Fenofibrate 145mg tablet was observed inside a 500-count product bottle.
The affected product is identified by NDC 68180-0519-02 (original) and 70518-0382-03 (repackaged). The specific lot number is J0322819-091418 with an expiration date of 09/30/2019. The distribution pattern is listed as PA.
Consumers should check their medication for the specific lot and expiration date listed above. If the product matches the recall details, they should stop using it and contact their pharmacist or healthcare provider for guidance on obtaining a replacement.
The recalled product
- Product
- Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original NDC of 500 count bottle); 70518-0382-03 (Repackaged NDC for blister cards).
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 480
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 #: J0322819-091418
- Exp: 09/30/2019
Distribution
Distributed in 1 state:
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