Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product description
Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07
Lot numbers, UPCs & expiration codes
11888415
Where it was sold
FL, GA, SC
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-0571-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 15, 2021
- FDA report date
- Jun 2, 2021
- Quantity
- 160 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cardinal Health Inc.
Original FDA data
Every field from FDA enforcement report D-0571-2021, exactly as published.
Show all FDA fields
- City
- Dublin
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 87512
- Address
- 7000 Cardinal Pl
- Code information
- 11888415
- Postal code
- 43017-1091
- Report date
- Jun 2, 2021
- Product type
- Drugs
- Recall number
- D-0571-2021
- Classification
- Class II
- Recalling firm
- Cardinal Health Inc.
- Product quantity
- 160 bottles
- Termination date
- Jun 17, 2024
- Reason for recall
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07
- Distribution pattern
- FL, GA, SC
- Recall initiation date
- Mar 15, 2021
- Initial firm notification
- Letter
- Center classification date
- May 24, 2021