D-1720-2019 Class II Terminated
FDA drug recall D-1720-2019 was initiated by Lupin Pharmaceuticals Inc. on July 17, 2019 and is designated Class II. Reason for recall: Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles. The recall status is terminated (terminated September 14, 2020). Affected quantity: 39,216 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 21, 2019
- Initiation Date
- July 17, 2019
- Termination Date
- September 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39,216 bottles
Product Description
Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, INDIA NDC 68180-518-01
Reason for Recall
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Distribution Pattern
Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.
Code Information
Batch# H900575, exp. date 01/2022