Why it was recalled
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Product description
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01.
Lot numbers, UPCs & expiration codes
Lot: PW05264, Exp. 11/2019
Where it was sold
Nationwide in the USA and Puerto Rico.
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-1206-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 21, 2018
- FDA report date
- Sep 19, 2018
- Quantity
- 46,632 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accord Healthcare, Inc.
Original FDA data
Every field from FDA enforcement report D-1206-2018, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 80850
- Address
- 1009 Slater Rd Ste 210B
- Code information
- Lot: PW05264, Exp. 11/2019
- Postal code
- 27703-8446
- Report date
- Sep 19, 2018
- Product type
- Drugs
- Recall number
- D-1206-2018
- Classification
- Class I
- Recalling firm
- Accord Healthcare, Inc.
- Product quantity
- 46,632 bottles
- Termination date
- May 7, 2020
- Reason for recall
- Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Aug 21, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 21, 2018