Why it was recalled
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Product description
children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.
Lot numbers, UPCs & expiration codes
Lot # 313344, Exp 12/18
Where it was sold
Nationwide in the USA
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-0278-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 19, 2018
- FDA report date
- Nov 21, 2018
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0278-2019, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 81483
- Address
- 3 Skyline Dr
- Code information
- Lot # 313344, Exp 12/18
- Postal code
- 10532-2174
- Report date
- Nov 21, 2018
- Product type
- Drugs
- Recall number
- D-0278-2019
- Classification
- Class II
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Termination date
- Nov 3, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 19, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2018