FDAFDA · Food and drugs·Recall number D-1052-2016
Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30
Published July 6, 2016 · Recall initiated: April 4, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- LISINOPRIL AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide and Puerto Rico
- UPC
- 0368180519010
- Lot
- Lot #: a) H303459, b) H303460, Exp 09/2016
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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