Why it was recalled
Presence of Particulate Matter
Product description
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01
Lot numbers, UPCs & expiration codes
Lot # 151379 and Lot #151380; Exp 12/16
Where it was sold
Nationwide
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-0565-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 29, 2015
- FDA report date
- Jan 20, 2016
- Quantity
- 2,784 cartons (278,400 capsules)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services
Original FDA data
Every field from FDA enforcement report D-0565-2016, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 72865
- Address
- 2550 John Glenn Ave
- Address (line 2)
- Suite A
- Code information
- Lot # 151379 and Lot #151380; Exp 12/16
- Postal code
- 43217-1188
- Report date
- Jan 20, 2016
- Product type
- Drugs
- Recall number
- D-0565-2016
- Classification
- Class II
- Recalling firm
- Amerisource Health Services
- Product quantity
- 2,784 cartons (278,400 capsules)
- Termination date
- Jan 11, 2017
- Reason for recall
- Presence of Particulate Matter
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 29, 2015
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2016