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.
Reported: September 28, 2016 Initiated: April 6, 2016 #D-1503-2016
Product Description
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.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 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.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 5,880 bottles.
Why was this product recalled? ▼
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 28, 2016. Severity: Low. Recall number: D-1503-2016.
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