Amlodipine Besylate Tablets USP recall: CGMP Deviations
Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Why was Amlodipine Besylate Tablets USP recalled?
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016
- Product
- Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
- Recalling firm
- Lupin Limited
- Quantity
- 11,812 bottles
- Distribution
- US No recalled product was distributed to any foreign consignees by Lupin.
- Recall date
- September 14, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)