Recalls / Class II
Class IID-0302-2020
Product
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04
- Affected lot / code info
- Lot #: A972834374, Exp 12/20
Why it was recalled
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 5,280 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-09-27
- FDA classified
- 2019-11-05
- Posted by FDA
- 2019-11-06
- Terminated
- 2023-08-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0302-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.