DrugNov 17, 2021
Acetaminophen Oral Suspension, 325 mg/10.15 mL recall — FDA D-0095-2022
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class IIFDA: TerminatedPrecision Dose Inc.
Recall history in this database
Classification mix: Class II: 6, Class III: 1.
DrugNov 17, 2021
Acetaminophen Oral Suspension, 160 mg/5 mL recall — FDA D-0094-2022
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class IIFDA: TerminatedPrecision Dose Inc.
DrugJan 20, 2021
Precision Dose Chlorhexidine Gluconate Oral Rinse USP 0.12% recall — FDA D-0228-2021
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Class IIFDA: TerminatedPrecision Dose Inc.
DrugMar 18, 2020
Precision Dose Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per recall — FDA D-1004-2020
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Class IIFDA: TerminatedPrecision Dose Inc.
DrugNov 8, 2017
Precision Dose Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups recall — FDA D-0057-2018
Subpotent Drug: low out of specification results.
Class IIIFDA: TerminatedPrecision Dose Inc.
DrugAug 9, 2017
Precision Dose Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups recall — FDA D-1037-2017
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Class IIFDA: TerminatedPrecision Dose Inc.
DrugApr 24, 2013
Precision Dose Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup recall — FDA D-250-2013
Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of…
Class IIFDA: TerminatedPrecision Dose Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Precision Dose Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.