Reported Sep 14, 2016 · Terminated
Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.…
Lupin Limited
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 Limited · 15-B, Phase 1A, Verna Industrial Area · Verna, Salcette, Goa · N/A
Is this the product you have?
- Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only
- Manufactured forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
- Manufactured by
Lupin Limited Goa 403 722 INDIANDC 68180-752-03
- Lot codes and dates
Lot #: G304677G304540G304536G304537G304535G304541G304545G304533G304532G304539G304538G304534Exp. 4/2016
- Amount recalled
- 11,812 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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