Why it was recalled
Failed Dissolution Specifications
Product description
Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01
Lot numbers, UPCs & expiration codes
Batch BFD1G001, exp 12/2021
Where it was sold
Nationwide 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-0166-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 25, 2020
- FDA report date
- Dec 9, 2020
- Quantity
- 2496 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharma Inc
Original FDA data
Every field from FDA enforcement report D-0166-2021, exactly as published.
Show all FDA fields
- City
- Levittown
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 86878
- Address
- 2091 Hartel Ave
- Code information
- Batch BFD1G001, exp 12/2021
- Postal code
- 19057-4506
- Report date
- Dec 9, 2020
- Product type
- Drugs
- Recall number
- D-0166-2021
- Classification
- Class I
- Recalling firm
- Torrent Pharma Inc
- Product quantity
- 2496 Bottles
- Termination date
- Dec 28, 2022
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Nov 25, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 16, 2020