Cetirizine Oral Solution 1 mg/mL — Class II drug recall D-1408-2019
Terminated recall by P & L Developments, LLC, reported 2019-06-26, distributed nationwide. cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the
| Recall number | D-1408-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | P & L Developments, LLC, Westbury, NY, United States |
| Recall initiated | 2019-06-05 |
| Classified | 2019-06-20 |
| Reported by FDA | 2019-06-26 |
| Terminated | 2020-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 17,664 bottles |
| Reason classes | cgmp |
| Pathogens | burkholderia |
| UPC / GTIN / UDI-DI | 00635515992474 |
| NDC | 63868-0430-04 |
| Lot numbers | 10/19, 12/19, 2/20, 8/20, C04866, C09863, F01267, F12609, F25327 |
Product
Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. Bottle, Distributed by C.D.M.A. Inc., Novi, MI 48376, Quality Choice, NDC 63868-430-04, UPC 635515992474.
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1408-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.