Why it was recalled
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Product description
Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India. NDC 16729-134-01
Lot numbers, UPCs & expiration codes
Lots: R2200455, R2200456 Exp. 03/2025
Where it was sold
Nationwide in the USA
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-0168-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 12, 2023
- FDA report date
- Feb 1, 2023
- Quantity
- 87,576 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Accord Healthcare, Inc.
Original FDA data
Every field from FDA enforcement report D-0168-2023, exactly as published.
Show all FDA fields
- City
- Durham
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 91499
- Address
- 1009 Slater Rd Ste 210B
- Code information
- Lots: R2200455, R2200456 Exp. 03/2025
- Postal code
- 27703-8446
- Report date
- Feb 1, 2023
- Product type
- Drugs
- Recall number
- D-0168-2023
- Classification
- Class II
- Recalling firm
- Accord Healthcare, Inc.
- Product quantity
- 87,576 bottles
- Termination date
- Apr 23, 2024
- Reason for recall
- Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India. NDC 16729-134-01
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 12, 2023
- Initial firm notification
- Letter
- Center classification date
- Jan 20, 2023