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.
Reported: September 25, 2019 Initiated: September 6, 2019 #D-1862-2019
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.
Reason for Recall
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Details
- Recalling Firm
- Torrent Pharma Inc.
- Units Affected
- 2472 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Basking Ridge, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Torrent Pharma Inc.. Units affected: 2472 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 25, 2019. Severity: Moderate. Recall number: D-1862-2019.
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