Recalls / Class II
Class IID-0383-2015
Product
Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8.
- Brand name
- Childrens Loratadine
- Generic name
- Loratadine
- Active ingredient
- Loratadine
- Route
- Oral
- NDC
- 51672-2092
- FDA application
- ANDA076805
- Affected lot / code info
- Lot #: A4105, Exp 12/2016
Why it was recalled
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
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, N/A, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 36,684 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-12-30
- FDA classified
- 2015-02-05
- Posted by FDA
- 2015-02-11
- Terminated
- 2018-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0383-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.