Class I · High risk
Anagrelide Capsules USP
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Anagrelide Capsules
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Failed Dissolution Specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01
Affected NDC
13668-0462-01
Compare with the code on your package — it is the most precise check available.
Drug: Anagrelide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| anagrelide NDC 13668-0462 |
HYDROCHLORIDE ANHYDROUS 1 mg/1 | Capsule Oral |
Torrent Pharmaceuticals Limited | Rx |
- Recalling firm
- Torrent Pharma Inc
- NDC code
- 13668-462-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0166-2021 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Anagrelide recalls
See all
Class II · Moderate risk
Anagrelide Capsules
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Class II · Moderate risk
Anagrelide HCL
Labeling: Label Mixup: ANAGRELIDE HCL, Capsule, 0.5 mg may have potentially been mislabeled as the following drug: ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD46414_1, EXP: 5/16/2014.
Other recalls by Torrent Pharma Inc
All 2020 recalls
Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP deviations: tablets cracking
Class II · Moderate risk
Carbamazepine Tablets
Failed Dissolution Specifications
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