Recalls / Class II
Class IID-1407-2019
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.
- Affected lot / code info
- 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.
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).
Recalling firm
- Firm
- P & L Developments, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Hicks St, N/A, Westbury, New York 11590-3323
Distribution
- Quantity
- 202,068 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-06-05
- FDA classified
- 2019-06-20
- Posted by FDA
- 2019-06-26
- Terminated
- 2020-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1407-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.