FDA Drug recall D-0278-2019
children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, D…
- FDA Drug
- Class II
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, D… by Taro Pharmaceuticals U, citing failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0278-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-19 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Taro Pharmaceuticals U |
| Distribution | US |
Product
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.
Reason
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Identifiers
| upc | 011822573634 |
|---|---|
| code_info | Lot # 313344, Exp 12/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Taro Pharmaceuticals U
- Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T…
FDA Drug · Class III · 2024-08-21 · Taro Pharmaceuticals U - Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd
FDA Drug · Class III · 2022-04-06 · Taro Pharmaceuticals U - Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dis…
FDA Drug · Class I · 2022-01-19 · Taro Pharmaceuticals U - Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd
FDA Drug · Class II · 2021-02-10 · Taro Pharmaceuticals U - Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
All Taro Pharmaceuticals U recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0278-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.