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BP Med Recalled
More than 25,000 bottles of lisinopril tablets are being recalled nationwide by Lupin Pharmaceuticals.
What’s the reason? Deviations in manufacturing practices prompted the recall as active pharmaceutical ingredients were used whose intermediates failed specifications, according to the US Food and Drug Administration’s Enforcement Report.
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Which lots are included in the Class III recall?
|
Presentation |
Lot |
Expiration |
|
30 mg |
H303487 |
September 2016 |
|
30 mg |
H303488 |
September 2016 |
|
30 mg |
H303489 |
September 2016 |
|
40 mg |
H303449 |
September 2016 |
The drugs were manufactured in India.
This is not the first time products made by Lupin have raised concern. In 2015, manufacturing practices at one of its plants that makes oral contraceptives received a Form 483 from the FDA.
Click here to read the report.
--Stephanie Vaccaro
Reference:
US Food and Drug Administration. FDA Enforcement Report – Week of July 6, 2016. www.fda.gov. Accessed July 11, 2016.
