Class I · High risk
Anagrelide Capsules USP
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Anagrelide Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What 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.
Affected NDC
13668-0453-01
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 13668-0453 |
HYDROCHLORIDE ANHYDROUS .5 mg/1 | Capsule Oral |
Torrent Pharmaceuticals Limited | Rx |
- Recalling firm
- Torrent Pharma Inc.
- NDC code
- 13668-453-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1862-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. 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 I · High risk
Anagrelide Capsules
Failed Dissolution Specifications
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 2019 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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