Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutiona
Summary
The FDA issued a Class II for Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tra by Plastikon Healthcare LLC. Reason: CGMP Deviations: Failure to properly investigate failed microbial testing..
Details
Source
Drug Recall
External ID
D-0869-2022
Action Date
2022-05-25
Status
Completed
Category
drug
Product Description
Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
Lot/Code Info: Lot: 20040A, EXP May 2022
Quantity Affected: 121,800 Unit Dose cups
Reason for Recall
CGMP Deviations: Failure to properly investigate failed microbial testing.
Distribution
Distributed in Indiana for further distribution in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-24
Company
Lawrence, KS
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 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Plastikon Healthcare LLC has 24 FDA actions in our database, including 24 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 (Plastikon Healthcare LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Plastikon Healthcare LLC have FDA actions?
Plastikon Healthcare LLC has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0869-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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