Why it was recalled
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Product description
Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.
Lot numbers, UPCs & expiration codes
Lot #: BFE2E003, Exp 08/31/2020
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-1862-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 6, 2019
- FDA report date
- Sep 25, 2019
- Quantity
- 2472 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-1862-2019, exactly as published.
Show all FDA fields
- City
- Basking Ridge
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83733
- Address
- 150 Allen Rd Ste 102
- Code information
- Lot #: BFE2E003, Exp 08/31/2020
- Postal code
- 07920-3856
- Report date
- Sep 25, 2019
- Product type
- Drugs
- Recall number
- D-1862-2019
- Classification
- Class II
- Recalling firm
- Torrent Pharma Inc.
- Product quantity
- 2472 bottles
- Termination date
- Nov 3, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Sep 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Sep 16, 2019