Precision Dose Inc. Recalls

All product recalls associated with Precision Dose Inc..

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Recall Summary

Total Recalls

7

Past Year

0

Class I (Serious)

0

Most Recent

Nov 2021

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–7 of 7 recalls

Acetaminophen Oral Suspension 160mg (Precision Dose) – Raw Ingredient Contamination (2021)

cGMP Deviations: Product manufactured with contaminated raw ingredient.

Class IIModerate

FDANov 1, 2021Nationwide• Precision Dose Inc.

Acetaminophen Oral Suspension 325mg (Precision Dose) – Raw Ingredient Contamination (2021)

cGMP Deviations: Product manufactured with contaminated raw ingredient.

Class IIModerate

FDANov 1, 2021Nationwide• Precision Dose Inc.

Chlorhexidine Oral Rinse (Precision Dose) – CGMP Deviation (2021)

cGMP deviations: The firm was notified of the manufacturer's expanded recall.

Class II

Moderate

FDAJan 1, 2021Nationwide• Precision Dose Inc.

Ranitidine Oral Solution (Precision Dose) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.

Class IIModerate

FDANov 13, 2019Nationwide• Precision Dose Inc.

Carbamazepine Oral Suspension (Precision Dose) – Subpotent Drug (2017)

Subpotent Drug: low out of specification results.

Class IIILow

FDASep 25, 2017Nationwide• Precision Dose Inc.

Carbamazepine Oral Suspension (Precision Dose) – Labeling Error (2017)

Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.

Class IIModerate

FDAJul 5, 2017CT, OH• Precision Dose Inc.

Children's Acetaminophen Suspension (Precision Dose) – Misleading Labeling (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 acetaminophen contained within it, is an adult dose.

Class IIModerate

FDAMar 21, 2013Nationwide• Precision Dose Inc.

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Precision Dose Inc. Recalls

Recall Summary

Acetaminophen Oral Suspension 160mg (Precision Dose) – Raw Ingredient Contamination (2021)

Acetaminophen Oral Suspension 325mg (Precision Dose) – Raw Ingredient Contamination (2021)

Chlorhexidine Oral Rinse (Precision Dose) – CGMP Deviation (2021)

Ranitidine Oral Solution (Precision Dose) – NDMA Impurity (2019)

Carbamazepine Oral Suspension (Precision Dose) – Subpotent Drug (2017)

Carbamazepine Oral Suspension (Precision Dose) – Labeling Error (2017)

Children's Acetaminophen Suspension (Precision Dose) – Misleading Labeling (2013)