Class III · Low risk
Sabril (vigabatrin)
Cross contamination with other products
Vigabatrin for Oral Solution
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Defective Container: powder may leak out of the pouch
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53
Affected NDC
69097-0964-53
Compare with the code on your package — it is the most precise check available.
Drug: Vigabatrin
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 |
|---|---|---|---|---|
| Vigabatrin NDC 69097-0964 |
500 mg/mL | Powder, for Solution Oral |
Cipla USA, Inc. | Rx |
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- NDC code
- 69097-964-53
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0220-2024 · 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 completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Vigabatrin recalls
See all
Class II · Moderate risk
Vigabatrin for Oral Solution
CGMP Deviations: recalling drug products following an FDA inspection.
Other recalls by InvaGen Pharmaceuticals, Inc.
All 2023 recalls
Class III · Low risk
Gabapentin Tablets USP
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Class III · Low risk
Testosterone Topical Solution 30mg of testosterone per pump…
Defective Container; actuator may improperly function and affect dose delivery.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter.
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