CLASS II Drug recall · Reported 26 Jun 2019 · FDA Enforcement Report
Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy recalled
P & L Developments is recalling Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten, distributed nationwide in the US. The recall was initiated on 5 Jun 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1407-2019
- FDA event ID
- 83181
- Recalling firm
- P & L Developments, Westbury, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2019
- FDA classified
- 20 Jun 2019
- Reported
- 26 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Allergy Medication
Timeline
| 5 Jun 2019 | Recall initiated by company | |
| 20 Jun 2019 | Classified by FDA | +15 days |
| 26 Jun 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Is Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten recalled?
Yes. P & L Developments recalled Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten on 5 Jun 2019. The recall is Class II and its status is Terminated. Recall number D-1407-2019.
Why was it recalled?
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).
Which lots are affected?
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.
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from P & L Developments
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg recalled | P & L Developments | Packaging Defects | Nationwide |
| Drug | CLASS II | Cetirizine Oral Solution 1 mg/mL, Children's Allergy recalled | P & L Developments | Sterility | Nationwide |
| Drug | CLASS II | Cetirizine Oral Solution 1 mg/mL, Up & Up recalled by P & L Developments | P & L Developments | Sterility | Nationwide |
Other Cetirizine recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cetirizine Hydrochloride Tablets USP 5 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Cetirizine Hydrochloride Tablets, USP, 10mg packs recalledCetirizine Hcl | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Cetirizine hydrochloride recalled by A-S Medication SolutionsCetirizine | A-S Medication Solutions | Other | 4 states |