D-1502-2016 Class III Terminated
FDA drug recall D-1502-2016 was initiated by Lupin Pharmaceuticals Inc. on Apr 6, 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 Aug 7, 2017). Affected quantity: 20,556 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 28, 2016
- Initiation Date
- Apr 6, 2016
- Termination Date
- Aug 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,556 bottles
Product Description
Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.
Reason for Recall
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Distribution Pattern
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.
Code Information
Batch number: H303487, H303488, H303489, Exp 09/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1502-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026