Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a)
Summary
The FDA issued a Class II for Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (N by Precision Dose Inc.. Reason: cGMP Deviations: Product manufactured with contaminated raw ingredient..
Details
Source
Drug Recall
External ID
D-0095-2022
Action Date
2021-11-17
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: Lot#: 503679, 503693, 503715
Quantity Affected: 151,100 unit dose cups
Reason for Recall
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-01
Company
South Beloit, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Precision Dose Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Precision Dose Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Precision Dose Inc. have FDA actions?
Precision Dose Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0095-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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