Reported Jun 26, 2019 · Terminated
Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Gluten Free, Grape Flavor, 5 mg/5mL,…
P & L Developments, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: P & L Developments, LLC · 200 Hicks St · Westbury, NY · 11590-3323
Is this the product you have?
- 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.
- Lot codes and dates
Lot #s: C00138A48440Exp. 5/19C02434C04186Exp. 6/19C07864Exp. 7/19F13277C08962F13778Exp. 10/19C11746F05899F13777Exp. 12/19F09356F10784F13595Exp. 2/20F22355F23239Exp. 8/20
- Amount recalled
- 202,068 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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