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
Reported: August 21, 2019 Initiated: July 17, 2019 #D-1720-2019
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.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 39,216 bottles
- Distribution
- Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 39,216 bottles.
Why was this product recalled? ▼
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 21, 2019. Severity: Moderate. Recall number: D-1720-2019.
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