Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.
Compare with the code on your package — it is the most precise check available.
Drug: Lisinopril Category: Blood Pressure Medication
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Lisinopril NDC 68180-0517 |
40 mg/1 | Tablet Oral |
Lupin Pharmaceuticals, Inc. | Rx |
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Failed content uniformity specifications.
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Presence of Foreign Substance
Presence of particulate matter: a white thread-like structure in the cartridge
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