Why it was recalled
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: A4105, Exp 12/2016
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0383-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 30, 2014
- FDA report date
- Feb 11, 2015
- Quantity
- 36,684 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0383-2015, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 70183
- Address
- 3 Skyline Dr
- Code information
- Lot #: A4105, Exp 12/2016
- Postal code
- 10532-2174
- Report date
- Feb 11, 2015
- Product type
- Drugs
- Recall number
- D-0383-2015
- Classification
- Class II
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 36,684 Bottles
- Termination date
- Jun 4, 2018
- Reason for recall
- Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 30, 2014
- Initial firm notification
- Letter
- Center classification date
- Feb 5, 2015