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.
Reported: June 8, 2022 Initiated: May 11, 2022 #D-0992-2022
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.
Reason for Recall
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Details
- Recalling Firm
- Teva Pharmaceuticals USA Inc
- Units Affected
- 4224 cartons
- Distribution
- Distributed Nationwide in the USA
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 4224 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 8, 2022. Severity: Critical. Recall number: D-0992-2022.
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