Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
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Based on the official records currently available to Public Health Trace, 1 recall naming Precision Dose Inc. is currently shown as ongoing. The other 7 records below are historical.
Public Health Trace has 8 recalls naming Precision Dose Inc. as the recalling firm, republished from official FDA and USDA sources.
Recall records - 8 total
Recalls by year
A bar chart of the number of recalls naming this company by year.
FDA RecallTerminatedTerminated: July 14, 2024Historical recordClass II
Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
by Precision Dose Inc.
Reason
cGMP Deviations: Product manufactured with contaminated raw ingredient.
FDA RecallTerminatedTerminated: July 14, 2024Historical recordClass II
Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.
by Precision Dose Inc.
Reason
cGMP Deviations: Product manufactured with contaminated raw ingredient.
FDA RecallTerminatedTerminated: July 14, 2024Historical recordClass II
Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.
by Precision Dose Inc.
Reason
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
FDA RecallTerminatedTerminated: September 17, 2022Historical recordClass II
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
by Precision Dose Inc.
Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
FDA RecallTerminatedTerminated: April 23, 2018Historical recordClass III
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
FDA RecallTerminatedTerminated: May 7, 2015Historical recordClass II
Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.
by Precision Dose Inc.
Reason
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.
Some FDA recall records on this page come from FDA's Enforcement Report database.
Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
This page lists recalls that name Precision Dose Inc. as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
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