Recalls / Class II
Class IID-0168-2023
Product
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
- Brand name
- Allopurinol
- Generic name
- Allopurinol
- Active ingredient
- Allopurinol
- Route
- Oral
- NDCs
- 16729-134, 16729-135
- FDA application
- ANDA203154
- Affected lot / code info
- Lots: R2200455, R2200456 Exp. 03/2025
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.
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Manufacturer
- Accord Healthcare Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 87,576 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-01-12
- FDA classified
- 2023-01-20
- Posted by FDA
- 2023-02-01
- Terminated
- 2024-04-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0168-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.