D-1492-2016 Class III Terminated
FDA drug recall D-1492-2016 was initiated by Lupin Limited on Feb 19, 2016 and is designated Class III. Reason for recall: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. The recall status is terminated (terminated Apr 3, 2017). Affected quantity: 43,536 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 14, 2016
- Initiation Date
- Feb 19, 2016
- Termination Date
- Apr 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43,536 bottles
Product Description
Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09
Reason for Recall
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Distribution Pattern
US No recalled product was distributed to any foreign consignees by Lupin.
Code Information
Lot #: G304799, Exp. 4/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1492-2016
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026