D-1052-2016 Class III Terminated
FDA drug recall D-1052-2016 was initiated by Lupin Pharmaceuticals Inc. on Apr 4, 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 Jun 1, 2017). Affected quantity: 59,520 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 6, 2016
- Initiation Date
- Apr 4, 2016
- Termination Date
- Jun 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59,520 Bottles
Product Description
Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30
Reason for Recall
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: a) H303459, b) H303460, Exp 09/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1052-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026