Reported Sep 28, 2016 · Terminated
Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore,…
Lupin Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174
Is this the product you have?
- Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only
- Manufactured forLupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States
- Manufactured byLupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03
- Lot codes and dates
- Batch number
H303449Exp 09/16
- Batch number
- Amount recalled
- 5,880 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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