FDA Drug recall D-1407-2019
Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz
- FDA Drug
- Class II
- terminated
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz by P And L Developments, citing cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamina….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1407-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-05 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | P And L Developments |
| Distribution | US |
Product
Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL, 4 FL. oz. Bottle, Distributed by Dolgencorp, LLC, 100 mission ridge, Goodlettsville, TN 37072, NDC 55910-878-04, UPC 359726178051.
Reason
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Identifiers
| upc | 359726178051 |
|---|---|
| code_info | Lot #s: C00138; A48440, Exp. 5/19; C02434; C04186, Exp. 6/19; C07864, Exp. 7/19; F13277; C08962; F13778, Exp. 10/19; C1…Lot #s: C00138; A48440, Exp. 5/19; C02434; C04186, Exp. 6/19; C07864, Exp. 7/19; F13277; C08962; F13778, Exp. 10/19; C11746; F05899; F13777, Exp. 12/19; F09356; F10784; F13595, Exp. 2/20; F22355; F23239, Exp. 8/20. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1407-2019%22
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