D-1346-2015 Class II Terminated
FDA drug recall D-1346-2015 was initiated by Wockhardt Usa Inc. on Jul 29, 2015 and is designated Class II. Reason for recall: CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. The recall status is terminated (terminated Apr 12, 2017). Affected quantity: 1704 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 26, 2015
- Initiation Date
- Jul 29, 2015
- Termination Date
- Apr 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1704 bottles
Product description
Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.
Reason for recall
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Distribution pattern
Nationwide
Code information
Lot #: DM12700, Exp 09/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1346-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026