Why it was recalled
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Product description
Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
Lot numbers, UPCs & expiration codes
Lot # GD01090, Exp 05/2022
Where it was sold
Distributed Nationwide in the USA
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-0992-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 11, 2022
- FDA report date
- Jun 8, 2022
- Quantity
- 4224 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0992-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90182
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot # GD01090, Exp 05/2022
- Postal code
- 07054-1120
- Report date
- Jun 8, 2022
- Product type
- Drugs
- Recall number
- D-0992-2022
- Classification
- Class I
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Product quantity
- 4224 cartons
- Termination date
- Feb 26, 2024
- Reason for recall
- Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- May 11, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 8, 2022