Precision Dose Inc.

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0095-2022Class IIAcetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 6November 1, 2021
D-0094-2022Class IIAcetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-November 1, 2021
D-0228-2021Class IIChlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack caseJanuary 1, 2021
D-1004-2020Class IIRanitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62;November 13, 2019
D-0057-2018Class IIICarbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in September 25, 2017
D-1037-2017Class IICarbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, July 5, 2017
D-250-2013Class IIChildren's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged March 21, 2013