Drug recall
Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye…
FDA recall event 81483 · Class II · Taro Pharmaceuticals U.S.A., Inc.
Key facts
| Event ID | 81483 |
|---|---|
| Recall numbers | D-0276-2019, D-0277-2019, D-0278-2019 |
| Recalling firm | Taro Pharmaceuticals U.S.A., Inc. |
| Product type | Drugs |
| Products | Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI…, children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. |
| Initiation date | Oct 19, 2018 |
| Report date | Nov 21, 2018 |
| Termination date | Nov 3, 2020 |
| City | Hawthorne |
| State | NY |
| Country | United States |
| FEI number | 2435212 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: