Recalls / Class II
Class IID-0298-2020
Product
Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8
- Brand name
- Ibuprofen
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDC
- 51672-1385
- FDA application
- ANDA209204
- Affected lot / code info
- Lot #: K779030125, Exp 10/19; D873031376, Exp 3/20; J871233188, Exp 9/20; L866934047, Exp 11/20; A973134376, 12/20; D967635229, Exp 3/21
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.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 138,886 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-0298-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.