Why it was recalled
Failed Dissolution Specifications; 18 month stability time point
Product description
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Lot numbers, UPCs & expiration codes
a) 30 count C500228, exp 12/2016, C500848 and C500850, exp 01/2017 C503651 and C503653, exp 04/2017, b) 100 count C500226, exp 12/2016, C500848, C500850, exp 01/2017, C503649 and C503653, exp 04/2017
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-0452-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 28, 2016
- FDA report date
- Feb 8, 2017
- Quantity
- a) 38,832 and b) 5,064 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0452-2017, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76122
- Address
- 107 College Rd E
- Code information
- a) 30 count C500228, exp 12/2016, C500848 and C500850, exp 01/2017 C503651 and C503653, exp 04/2017, b) 100 count C500226, exp 12/2016, C500848, C500850, exp 01/2017, C503649 and C503653, exp 04/2017
- Postal code
- 08540-6623
- Report date
- Feb 8, 2017
- Product type
- Drugs
- Recall number
- D-0452-2017
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- a) 38,832 and b) 5,064 bottles
- Termination date
- Oct 19, 2017
- Reason for recall
- Failed Dissolution Specifications; 18 month stability time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 28, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 30, 2017