D-1077-2018 Class II Terminated
FDA drug recall D-1077-2018 was initiated by Lupin Pharmaceuticals Inc. on Aug 13, 2018 and is designated Class II. Reason for recall: Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet. The recall status is terminated (terminated Oct 15, 2019). Affected quantity: 11,706 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 22, 2018
- Initiation Date
- Aug 13, 2018
- Termination Date
- Oct 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,706 bottles
Product Description
Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03
Reason for Recall
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Distribution Pattern
Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States.
Code Information
Lot #: H800414, Exp. 12/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1077-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026