FDAFDA · Food and drugs·Recall number D-1503-2016
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.
Published September 28, 2016 · Recall initiated: April 6, 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
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.
- UPC
- 0368180513018
- Lot
- Batch number: H303449, Exp 09/16
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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