Drug recall D-1503-2016
Product
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.
Reason for recall
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lots and codes
Batch number: H303449, Exp 09/16
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 5,880 bottles
- Distribution
- 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.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 6, 2016
- Terminated
- August 7, 2017
Related products
- Lisinopril – drug information
- NDC 68180-982 Lisinopril · Lisinopril 30 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-514 Lisinopril · Lisinopril 10 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-517 Lisinopril · Lisinopril 40 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-513 Lisinopril · Lisinopril 5 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-980 Lisinopril · Lisinopril 10 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-979 Lisinopril · Lisinopril 40 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-515 Lisinopril · Lisinopril 20 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-512 Lisinopril · Lisinopril 2.5 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-516 Lisinopril · Lisinopril 30 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-981 Lisinopril · Lisinopril 20 mg/1 · Lupin Pharmaceuticals, Inc.