Why it was recalled
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the 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
Lot numbers, UPCs & expiration codes
Batch# H900575, exp. date 01/2022
Where it was sold
Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1720-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 17, 2019
- FDA report date
- Aug 21, 2019
- Quantity
- 39,216 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1720-2019, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 83354
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Batch# H900575, exp. date 01/2022
- Postal code
- 21202-6174
- Report date
- Aug 21, 2019
- Product type
- Drugs
- Recall number
- D-1720-2019
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 39,216 bottles
- Termination date
- Sep 14, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.
- Recall initiation date
- Jul 17, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 9, 2019