P & L Developments recalls
FDA enforcement reports naming P & L Developments, LLC as the recalling firm.
- Recall reports
- 6
- Class I (serious)
- 0
- Most recent report
- Oct 7, 2020
- Oct 7, 2020Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton…Drug · P & L Developments, LLCLabeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.Class III
- Jun 26, 2019Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Glut…Drug · P & L Developments, LLCcGMP 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.cepaci…Class II
- Jun 26, 2019Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dy…Drug · P & L Developments, LLCcGMP 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.cepaci…Class II
- Jun 26, 2019Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free, Grape Fl…Drug · P & L Developments, LLCcGMP 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.cepaci…Class II
- May 7, 2014Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylep…Drug · P&L Developments, LLCPresence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.Class III
- Apr 30, 2014Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Ph…Drug · P&L Developments, LLCSubpotent Drug: Phenylephrine component is subpotent.Class III