Drug product
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
D-0390-2026
Product summary
- Event
- Event 98508
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 89592 bottles
- Official record key
drug-enforcement:D-0390-2026
Official wording
Reason: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Code information: Lot: 7261973A, 7261974A, Exp 01/31/2027
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign substance