Why it was recalled
Presence of Particulate Matter.
Product description
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93.
Lot numbers, UPCs & expiration codes
T084M14A, T085M14A, T086M14A; 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-0232-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 7, 2015
- FDA report date
- Nov 25, 2015
- Quantity
- 912 HDPE bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-0232-2016, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 72397
- Address
- 150 Vintage Dr NE
- Code information
- T084M14A, T085M14A, T086M14A; Exp 12/16
- Postal code
- 35811-8216
- Report date
- Nov 25, 2015
- Product type
- Drugs
- Recall number
- D-0232-2016
- Classification
- Class II
- Recalling firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Product quantity
- 912 HDPE bottles
- Termination date
- Nov 16, 2016
- Reason for recall
- Presence of Particulate Matter.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 7, 2015
- Initial firm notification
- Letter
- Center classification date
- Nov 13, 2015