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
Reported: January 17, 2024 Initiated: November 17, 2023 #D-0220-2024
Product Description
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
Reason for Recall
Defective Container: powder may leak out of the pouch
Details
- Recalling Firm
- InvaGen Pharmaceuticals, Inc.
- Units Affected
- 1240 boxes
- Distribution
- Nationwide within the United States
- Location
- Central Islip, NY
Frequently Asked Questions
What product 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. Recalled by InvaGen Pharmaceuticals, Inc.. Units affected: 1240 boxes.
Why was this product recalled? ▼
Defective Container: powder may leak out of the pouch
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 17, 2024. Severity: Critical. Recall number: D-0220-2024.
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